Pfizer

Nervous system symptom reports

Female, 26 - 39 years

Age Reported Symptoms Notes
26 2020-12-31 dizziness Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat.... Read more
Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  
26 2021-01-01 pain Fever of 101, chills, severe body aches, mild headache, nausea, pain at injection site
26 2021-01-01 dizziness Pale and light headed. Given water, ice pack for neck. Rested and monitored for 30 minutes and left... Read more
Pale and light headed. Given water, ice pack for neck. Rested and monitored for 30 minutes and left walking and without symptoms.
26 2021-01-01 tingling, numbness Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I ... Read more
Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I began to feel fatigue around 7 pm that afternoon and fell asleep. When I woke up at midnight on 12/30/20 I noticed numbness beginning in my left foot and spreading into my face over a course of 30 minutes. I never noted any muscle weakness, but felt a tingling sensation on the left side of my body. Then I began to experience chills and sweating. I was able to return to sleep around 2 AM. When I woke up at 5:30 the numbness had resolved.
26 2021-01-03 dizziness At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; hea... Read more
At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; heart rate 98bpm; SPO2 99% on room air; Placed in supine position in observation area. Administered Benedryl 50mg oral at 3:25pm; Blood pressure was rechecked at 3:40pm; 141/91; heart rate 88; associated states she felt improved of all symptoms; associate has been cleared to return home; husband will transport
26 2021-01-03 balance disorder, pain By evening, arm around the injection site grew increasingly painful, to the point where it hurt to m... Read more
By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31
26 2021-01-03 migraine Migraine; Feeling foggy; Malaise; Swollen lymph nodes; Could not lift arm more than a few inches
26 2021-01-03 pain in extremity, numbness On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outsi... Read more
On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.
26 2021-01-03 pain in extremity Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, exp... Read more
Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, experiencing increased joint pain on left wrist and thumb as well as swelling at base of thumb and inability to move, pinch, grab, stretch left hand. Occasionally pain spread up left forearm to elbow.
26 2021-01-04 pain in extremity Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-ye... Read more
Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on the right arm on 28Dec2020 16:00 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced arm tenderness on 28Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
26 2021-01-04 dizziness, pain I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; ... Read more
I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
26 2021-01-04 pain Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at abo... Read more
Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at about 11:30pm. Took a Tylenol at that time. Low grade fever still persists (and rose to 100 degrees at the highest), mild body aches at 6am and headache.
26 2021-01-04 facial paralysis, tingling, numbness The night after the covid vaccine, the patient started experiencing left-side facial numbness and ti... Read more
The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given.
26 2021-01-04 pain in extremity mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; m... Read more
mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.
26 2021-01-05 tenderness -Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flu... Read more
-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs
26 2021-01-05 pain Fever of 100.3, headache, chills, body aches
26 2021-01-05 numbness Numbness in hand Narrative: Numbness in left fingers lasted 10-15 minutes
26 2021-01-05 difficulty speaking Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began... Read more
Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration
26 2021-01-05 lightheadedness Pt experienced a pre-syncopal/vasovagal episode. She was laid supine and observed for 25-30 minutes... Read more
Pt experienced a pre-syncopal/vasovagal episode. She was laid supine and observed for 25-30 minutes. She began to feel better and was able to sit and then stand with no symptoms. She felt able to leave the clinic on her own and was advised to seek medical attention should symptoms return or worsen.
26 2021-01-05 dizziness, tingling Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitat... Read more
Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.
26 2021-01-05 pain Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spo... Read more
Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.
26 2021-01-05 pain Woke up at 0400hrs with a temperature of 99.7, body wide pain, exhaustion, and a headache. Fever rea... Read more
Woke up at 0400hrs with a temperature of 99.7, body wide pain, exhaustion, and a headache. Fever reached 100.00 by 0530hrs. Fever subsided by 1200hrs. Slept majority of the day. Symptoms went away around 1730hrs.
26 2021-01-06 restlessness, pain in extremity 12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- ext... Read more
12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.
26 2021-01-06 pain, tremor I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body a... Read more
I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body aches for approximately 2 days. The third day I woke up without any symptoms.
26 2021-01-06 restlessness Skin hurting Restlessness Fever Headache Shortness of breath Seeing flashes Malaise Muscle aches
26 2021-01-06 feeling cold patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms ... Read more
patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal
26 2021-01-07 weakness, dizziness 24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in ... Read more
24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness. These symptoms are ongoing.
26 2021-01-07 weakness, dizziness About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, ... Read more
About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.
26 2021-01-07 pain Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is ... Read more
Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
26 2021-01-07 pain Fever, chills, body ache, headache
26 2021-01-07 pain Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of inje... Read more
Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain
26 2021-01-07 feeling hot, pain, feeling of body temperature change, dizziness Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, ... Read more
Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.
26 2021-01-07 pain in extremity Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet an... Read more
Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.
26 2021-01-07 pain in extremity Rigors, fever, headache and arm soreness
26 2021-01-07 pain in extremity, numbness, migraine Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursd... Read more
Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8; Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved; Sunday 1/3 extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.
26 2021-01-07 pain a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight f... Read more
a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient). A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm for COVID-19 immunization. Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.
26 2021-01-07 numbness mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower ... Read more
mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.
26 2021-01-07 pain temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a co... Read more
temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown. Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-01-08 dizziness Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my thro... Read more
Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site
26 2021-01-08 pain Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches... Read more
Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches (severe aches in my lower back and hips). This lasted the entire day until I went to bed around 10 o'clock. I had to use a heating pad for my back to reduce the pain.
26 2021-01-08 pain Body ache, headache, fatigue.
26 2021-01-08 pain Fatigue, body aches for 48 hours.
26 2021-01-08 pain On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and... Read more
On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and swollen left axillary lymph nodes. I took Tylenol and Benadryl and it relieved the fever/headache/body aches/joint pain, however the lymph nodes in my left axillary remained swollen. I continue to take Tylenol for the fever/body aches/pains without relief for the swollen and painful axillary lymph nodes. Warm compresses do help to relieve the pain temporarily but they remain painfully swollen. On 01/08/21 I called my doctors office to ask if it was normal to experience such painfully swollen axillary lymph nodes to which they stated ?we don?t know, it is too soon for us to tell what?s normal and what isn?t normal right now.? They did not offer any suggestions to relieve the pain or swelling. The morning of 01/09/2021 , I called Employee Health at my hospital (my place of work and also where I received the vaccine) and they also stated they didn?t know if this was a normal reaction due to the newness of the vaccine. A couple hours later, employee health emailed me a link to the VAERS reporting website and asked me to file a report.
26 2021-01-08 pain in extremity Pain and swelling in left arm and axilla that radiates to her back for 9 hours.
26 2021-01-08 dizziness Severe headache Dizziness Fatigue
26 2021-01-09 pain FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 ... Read more
FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 days took tylenol
26 2021-01-09 pain in extremity Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sle... Read more
Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache
26 2021-01-09 pain in extremity Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm... Read more
Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.
26 2021-01-10 pain 4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, b... Read more
4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, body aches, headache, and was fatigued. These symptoms lasted until about 7pm until I took Tylenol. Once I took Tylenol I felt almost immediately better.
26 2021-01-10 weakness, tingling Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was n... Read more
Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.
26 2021-01-10 pain Body aches at 9:00am Chills at 9:00 am Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at ... Read more
Body aches at 9:00am Chills at 9:00 am Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at 1:00pm Last from 12/22/2020 - 12/24/2020
26 2021-01-10 pain CHILLS, LOW GRADE FEVER AND BODY ACHES. SYMPTOMS LASTED 8 HOURS AND SUBSIDED RELATIVELY QUICKLY.
26 2021-01-10 pain Extreme body aches, chills, joint pain, fatigue. 800mg ibuprofen taken which somewhat relieved symp... Read more
Extreme body aches, chills, joint pain, fatigue. 800mg ibuprofen taken which somewhat relieved symptoms, but not completely.
26 2021-01-10 pain, pain in extremity Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day an... Read more
Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day and continuing for about a week and a half (so far) Mild body aches/ malaise the day after Fatigue next day and for next week and a half (so far) afterwards
26 2021-01-10 weakness, tingling, feeling cold Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; ... Read more
Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.
26 2021-01-10 seizure, tingling, numbness Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after v... Read more
Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital.
26 2021-01-10 pain Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore... Read more
Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore throat about 1 hour after vaccine was administered at a hospital setting and was seen about 6 hours later a different medical office. These symptoms gradually became worse throughout the day. Patient was given Benadryl 25 mg oral syrup one time and emergency medical services were called to the clinic. Patient was transported to the emergency room by paramedics. Patient was called today by provider for a wellness check and notes shortness of breath and sensation of throat swelling resolved after being treated by paramedics and emergency room providers. Patient states she is overall feeling much better.
26 2021-01-10 pain Severe headache, body aches, fatigue, congestion starting approx. 12 hours after vaccination. Sympto... Read more
Severe headache, body aches, fatigue, congestion starting approx. 12 hours after vaccination. Symptoms subsided within 48 hours.
26 2021-01-10 dizziness, pain Within seconds increased heart rate shortness of breath light headedness and dizziness but thought i... Read more
Within seconds increased heart rate shortness of breath light headedness and dizziness but thought it could have been anxiety. Did not say anything and sat there for the 15 minutes with continued shortness of breath and high rate think it was anxiety. When the time was up I continued to stay at the hospital for an hour due to fear of bad reaction. Started to become extremely nauseous within 30 minutes and loss of appetite. Went to bed and woke up with a terrible headache, body aches, extreme fatigue and a 100.3 degree fever. Slept for 8 hours during the day waking up due to the pain in my body and chills but the symptoms went away by 5 pm the following day of the shot.
26 2021-01-10 pain Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a... Read more
Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a mild fever of 99.3F (baseline usually around 96.5-97.0). I took some Tylenol to elevate symptoms.
26 2021-01-10 pain fever, headache, nausea, body aches, fatigue-symptoms resolved
26 2021-01-11 pain Fevers of 102, chills, night sweats, body aches, headaches, nausea.
26 2021-01-11 dizziness Nausea, Dizzy, Headache
26 2021-01-11 tingling Pt reported shortly after receiving her vaccine that she had tingling feeling on the top of her head... Read more
Pt reported shortly after receiving her vaccine that she had tingling feeling on the top of her head, bilateral wrists, mid back, and right lower extremity. This was coming and going and had not happened the last about 10 minutes she was in the clinic.
26 2021-01-11 tingling, numbness Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face n... Read more
Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right ear feeling blocked 2 weeks post vaccine; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 at a single dose for covid-19 vaccination. Medical history included migraine. The patient has no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received her most recent COVID-19 vaccine in a hospital. The patient had right sided face numb/tingling with no drooping or asymmetry and right ear feeling blocked 2 weeks post vaccine (30Dec2020). The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the adverse event. The adverse event result in emergency room/department or urgent care. The event was considered as non-serious. The outcome of the events was recovering.
26 2021-01-11 pain in extremity Sore arm low grad fever week later, lymph node on arm pit was swollen and tender
26 2021-01-11 pain in extremity, pain Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side ... Read more
Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side arm pit
26 2021-01-11 pain in extremity Sore arm low grade fever week later, lymph node on arm pit was swollen and tender
26 2021-01-11 tingling Tingling to right fingers and palm. No other symptoms, no treatment, resolved.
26 2021-01-11 pain chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fat... Read more
chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue
26 2021-01-11 dizziness, pain headaches, nausea, body aches, chills, sore throat, fatigue, light headedness approximately 12 hour... Read more
headaches, nausea, body aches, chills, sore throat, fatigue, light headedness approximately 12 hours after administration which continued for a few days after. Medicated with Ibuprofen to manage pain.
26 2021-01-11 tremor palpitation, redness and tremulous
26 2021-01-12 dizziness ?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with h... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER
26 2021-01-12 pain Fevers, chills, body aches experienced at 0200 on 1/12. Vaccine was received at 1100 on 1/11.
26 2021-01-12 dizziness Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Patient visi... Read more
Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Patient visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher. Patient was alert, then laid down on stretcher and given water. Emergency response team called and team arrived on unit within 10 minutes. Vitals taken and follow: BP: 94/50 HR: 49, spO2: 100%. Patientt reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after a total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109. Emergency rsponse physician cleared patient. Patient walked around clinic with RN prior to exiting. Denied any distress. Independently exited clinic.
26 2021-01-12 dizziness Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Was visibly ... Read more
Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Was visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher. Patient was alert, then laid down on stretcher and given water. Emergency response team was called and team arrived on unit within 10 minutes. Vitals on arrival include BP: 94/50 HR: 49, spO2: 100%. Patient reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109. Emergency response physician cleared patient. Patient walked with around with clinic RN prior to leaving. Denies any distress. Independently exited clinic.
26 2021-01-12 dizziness Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyp... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.
26 2021-01-12 dizziness Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperve... Read more
Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER
26 2021-01-12 pain, migraine Rash, body aches, migraine
26 2021-01-12 dizziness, pain in extremity, tremor, pain, one side paralysis Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, swea... Read more
Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.
26 2021-01-12 tremor, pain Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. Thi... Read more
Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
26 2021-01-12 pain fever, body aches. called in sick to work.
26 2021-01-12 nerve pain, pain in extremity first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like ner... Read more
first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.
26 2021-01-12 pain in extremity headache, fever, chills and pain in arm
26 2021-01-13 dizziness 10 ' after vaccine, developed roof mouth tingling , dizziness , tachycardia and Left arm tingling .
26 2021-01-13 balance disorder, tremor, pain About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - ... Read more
About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)
26 2021-01-13 pain Body aches and Fever
26 2021-01-13 pain Fever (101.2), significant body aches, nausea
26 2021-01-13 pain Fever and Body Aches
26 2021-01-13 pain Fever, chills, body aches, nausea, headache
26 2021-01-13 pain I did okay with the first dose only experienced site pain and fatigue. This second dose has not been... Read more
I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.
26 2021-01-13 feeling hot Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolve... Read more
Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolved by am
26 2021-01-13 dizziness Patient reported feeling like her heart was racing approximately 5 minutes after receiving the injec... Read more
Patient reported feeling like her heart was racing approximately 5 minutes after receiving the injection and feeling dizzy as well. Heart rate and blood pressure were elevated with normal pulse ox. After approximately an hour pulse ox remained normal, but heart rate and blood pressure remained elevated. Patient was referred to emergency department for further evaluation.
26 2021-01-13 feeling hot Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observa... Read more
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.
26 2021-01-13 weakness Systemic: shaky, weak, tachycardic, gave O2, pt has heart issues already
26 2021-01-14 tingling, tremor, pain in extremity 12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described a... Read more
12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).
26 2021-01-14 dizziness 24hrs after shot felt fine I til about 30hrs then felt lightheaded, dizzy, and nauseous. Vomited on... Read more
24hrs after shot felt fine I til about 30hrs then felt lightheaded, dizzy, and nauseous. Vomited once. The next day (~42hrs after shot) spiked fever 101.2 and continued to feel dizzy but less nauseous. Took 800mg Motrin at 5am on 1/15/21
26 2021-01-14 tingling Complained of tingling entire left arm. No other symptoms.
26 2021-01-14 tingling I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart ra... Read more
I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.
26 2021-01-14 tingling Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vacc... Read more
Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.
26 2021-01-14 dizziness Severe headache lasting 2-3 days; fever; chills; light-headedness; Fatigue; This is a spontaneous re... Read more
Severe headache lasting 2-3 days; fever; chills; light-headedness; Fatigue; This is a spontaneous report from a contactable health care professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 23Dec2020 at 08:00 AM (at the age of 26-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 17:00 PM, the patient experienced severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. The patient did not receive any treatment for the severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue was recovered.
26 2021-01-14 dizziness Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C)... Read more
Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C), nauseas, dizzines, shaking chills and lost smell. Vomiting starts at 9:25 pm end 2:00 am. 01/08/2021 at 2:26 am visit Emergency Room, in clinic fainted and present high blood pressure 155/99. In hospital medication administred: Zofran, pepcid, .45 NSS and Phenergan IM at 01-08-2021.
26 2021-01-14 pain in extremity severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and musc... Read more
severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle. Information on the lot/batch number has been requested.
26 2021-01-15 pain Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injecti... Read more
Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injection ( this happened when I got my first one too)
26 2021-01-15 tremor, dizziness Fatigue, dizziness, confusion, tremors, brain fog, irregular menstrual period
26 2021-01-16 pain, pain in extremity Low grade fever, chills, body aches, headache, arm soreness
26 2021-01-17 dizziness Dizzy, Shortness of breath, Tachycardia.
26 2021-01-17 pain I got the shot around 4:30PM on Friday and woke up in the middle of the night that night with a feve... Read more
I got the shot around 4:30PM on Friday and woke up in the middle of the night that night with a fever (100.5) and aches. I had both symptoms all through Saturday as well. I was also very tired and slept most of the day Saturday. When I woke up on Sunday I felt totally fine again.
26 2021-01-17 migraine, pain Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; F... Read more
Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
26 2021-01-19 dizziness Dizziness, vomiting, fever, chills
26 2021-01-19 pain Fatigue, body aches, injection site pain, chills
26 2021-01-19 pain Fever (100.4), chills, nausea and severe joint and body aches
26 2021-01-19 pain Headache, fatigue, body ache, injection sore soreness
26 2021-01-19 tenderness, pain in extremity Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm ... Read more
Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.
26 2021-01-19 numbness Hives noted the following morning that were described as red, hot and itchy. Located on chest, head... Read more
Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.
26 2021-01-19 feeling cold I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this ... Read more
I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this point. The night of 1/13/21, I fell asleep but awoke multiple times cold. I experienced the chills through about midnight. The next morning, 1/14/21, I woke up with a headache at about 5:30am. I took a dose of Aleve and the symptoms had subsided by about 6:30am
26 2021-01-19 pain Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, sor... Read more
Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives
26 2021-01-19 dizziness My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second ... Read more
My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.
26 2021-01-19 dizziness Pt received the vaccine dose 2 and was sitting in the observation area when she stated that she was ... Read more
Pt received the vaccine dose 2 and was sitting in the observation area when she stated that she was feeling lightheaded and felt like she was going to pass out. This reaction occurred within 15 minutes of receiving the vaccine. Pt was pale, sweaty, diaphoretic, hypotensive and had bradycardia. Pt's systolic BP was in the 60s and her diastolic was in the 30s. Pt was offered food but refused. Pt was immediately brought to the ER where her care was transferred to an ER nurse.
26 2021-01-19 dizziness Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was ... Read more
Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was administered along with O2 at that time. Sent to ER.
26 2021-01-19 dizziness pt started feeling light headed and sweaty within 5 min of vaccination. pt didn't report symptoms un... Read more
pt started feeling light headed and sweaty within 5 min of vaccination. pt didn't report symptoms until 2 hours later, when she was given 25 mg of diphenhydramine. then she was being monitored every 60 min for changes
26 2021-01-19 pain in extremity sore arm for a day
26 2021-01-21 numbness, tingling, bell's palsy 26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states sh... Read more
26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.
26 2021-01-21 feeling hot, restlessness, pain, dizziness 3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous s... Read more
3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating. 24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep. 30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use. 48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.
26 2021-01-21 numbness, tingling, pain First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated ... Read more
First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.
26 2021-01-24 pain, tremor, pain in extremity Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Se... Read more
Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.
26 2021-01-24 nerve pain Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (p... Read more
Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting. The reporter considered that the event was non-serious. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
26 2021-01-24 migraine, weakness, feeling cold, pain Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got... Read more
Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.
26 2021-01-25 pain in extremity Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced ... Read more
Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.
26 2021-01-25 pain Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-ol... Read more
Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 11Jan2021 (10:45) at a single dose for COVID-19 immunization at the hospital. Medical history included hypothyroidism and allergy to sulfa drugs. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 21Dec2020 (when the patient was 26 years old) for COVID-19 immunization. On 12Jan2021 (02:00), the patient had fevers, chills and body aches. The patient had received an unspecified over-the-counter (OTC) pain reliever and an unspecified ointment as treatment for the reported events. The outcome of the events, 'fevers', 'chills' and 'body aches', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
26 2021-01-25 pain Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5... Read more
Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 06Jan2021 at 12:45 at single dose for COVID-19 immunization. The patient medical history included known allergies to sulfa medications from an unknown date and unknown if ongoing. The patient's concomitant medication included cholecalciferol (D3), cyanocobalamin (B12-VITAMIN), ascorbic acid, beta-carotene, calcium sulfate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The patient reported she was pregnant at the time of vaccination. She was at 5 weeks gestational period; last menstrual date was 01Dec2020 and will be due to deliver on 06Sep2021. On 07Jan2020 at 6.00, the patient experienced fever of 101.5 F, headache and body aches. The patient outcome of the events was recovered.
26 2021-01-25 pain Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report ... Read more
Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering. Information on the lot/ batch number has been requested.
26 2021-01-26 pain Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throa... Read more
Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throat Intermittent nausea Elevated HR Has lasted two days after vaccination and caused me to miss work
26 2021-01-26 pain Headache, body ache, chills, feel feverish
26 2021-01-26 migraine, pain in extremity I had a very sore arm which is normal, however the day after I received the vaccine I was extremely ... Read more
I had a very sore arm which is normal, however the day after I received the vaccine I was extremely nauseous and I threw up 5x at 7:30 AM. I had a migraine the rest of the day and was extremely tired, sleeping a total of 19 hours.
26 2021-01-26 pain in extremity Sore arm day off and for 48 hours following, severe abdominal pain approx 36 hours after injection
26 2021-01-26 numbness Symptoms from the Pfizer vaccine has been numb like feeling in the face, arms, legs, and hands. Thes... Read more
Symptoms from the Pfizer vaccine has been numb like feeling in the face, arms, legs, and hands. These symtoms arised Saturday Jan. 23, 2021 (a day after vaccine). Within the next couple of days, symtoms were still present, and presented more frequently throughout the days. Occuring more than 4 times a day.
26 2021-01-26 dizziness, vertigo Vertigo/dizziness; getting better at 1/27 11AM but still experiencing spells of dizziness
26 2021-01-26 pain fatigue; Chills; headache; body aches; This is a spontaneous report from a non-contactable Other HCP... Read more
fatigue; Chills; headache; body aches; This is a spontaneous report from a non-contactable Other HCP. A 26-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), intramuscular on the left arm on 12Jan2021 08:30 at single dose for COVID-19 immunization. The patient medical history included allergies. Concomitant medication included unspecified medication. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on 22Dec2020, intramuscular on the left arm. The patient experienced fatigue, chills, headache and body aches on 13Jan2021 06:00. The patient was recovering from the events. No treatment was received in response to the events. No follow-up attempts are possible. Information on lot/batch cannot be obtained.
26 2021-01-26 weakness, dizziness syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report ... Read more
syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-01-27 weakness, pain chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report fro... Read more
chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.
26 2021-01-27 pain in extremity, lethargy, pain, feeling cold severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib... Read more
severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
26 2021-01-28 pain Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection si... Read more
Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)
26 2021-01-28 pain Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nur... Read more
Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination. Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days. The patient is now feeling fine, all events have improved. She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition. She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report. No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.
26 2021-01-28 feeling cold Feeling cold in the afternoon 1/28/2021. 101 fever on 1/29/2021.
26 2021-01-28 pain in extremity Tachycardia first 10 minutes, soreness in arm for 3 days and fatigue following day.
26 2021-01-28 pain Woke up the following morning with a headache, fever, body aches, stomach ache
26 2021-01-28 pain fatigue, body aches, back pain, pain at injection site
26 2021-02-02 pain in extremity, weakness, pain Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for... Read more
Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting my OBGYN know at the next appointment.
26 2021-02-03 numbness, tingling Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and low... Read more
Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and lower extremities; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 26-years-old female patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3302, via an unspecified route of administration in right arm on 19Jan2021 at 17:30, at 26 years of age, at single dose for COVID-19 immunization as she was a front line worker. The vaccine was administered at the facility where the patient works. The patient had no relevant medical history and no concomitant medications. On 19Jan2021, about 20 minutes after receiving the vaccine dose (also reported at 18:00) she started having nonstop numbness and tingling in both feet and lower extremities, which has been going on for 46 hours straight. The events were assessed as medically significant, although a visit to emergency room or physician office was not required. The nurse reported that a doctor mentioned Guillain-Barre Syndrome which can lead to progressive muscle weakness and damaged nerves and she is severely concerned, although she has no health history. At the time of the report the reported events had not recovered yet. The reporter assessed the event related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Method of assessment: Global Introspection).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-03 pain tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fev... Read more
tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
26 2021-02-07 pain 35 weeks pregnant, fever of 102 chills, body aches and head pressure
26 2021-02-07 inability to speak, migraine, feeling cold mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of... Read more
mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-17 tingling, dizziness Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tinglin... Read more
Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On 02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-18 pain in extremity, pain, tingling neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most co... Read more
neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
26 2021-02-22 feeling hot Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadry... Read more
Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.
26 2021-02-28 pain Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding i... Read more
Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.
26 2021-02-28 pain decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous repor... Read more
decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization. Relevant medical history was reported as none and concomitant medication was not reported. The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular). The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms. Patient experienced decrease appetite on unspecified date with outcome of unknown. The other HCP consider the Pfizer product had a causal effect to the adverse event.
26 2021-03-01 speech disorder, pain It seems like she was drunk; it was almost like disorientation like; Had trouble processing like for... Read more
It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
26 2021-03-02 lethargy, migraine Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; S... Read more
Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
26 2021-03-02 vertigo, dizziness vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other he... Read more
vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other health professional (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on left arm on 19Jan2021 12:15 at single dose for COVID-19 immunisation at hospital. Medical history included depression and anxiety. The patient had no allergies to medications, food, or other products. Concomitant medication included trazodone at 100 mg and sertraline at 150 mg; both are received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, two weeks after vaccine (on 01Feb2021 22:00) the patient had onset of vertigo, light headedness, and nausea. Patient still experiencing vertigo 12 hours later. Did not imbibe alcohol or substances. Did not do strenuous activity. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.
26 2021-03-03 pain in extremity, dizziness, tenderness High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is sti... Read more
High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.
26 2021-03-09 pain in extremity Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the a... Read more
Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the arm entirely; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jan2021 10:30 (at the age of 26-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included gabapentin (MANUFACTUTERE UNKNOWN), fish oil (MANUFACTUTERE UNKNOWN), ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 13:00, the patient experienced extreme arm soreness which is getting progressively worse and making it difficult to lift or move the arm entirely. Seriousness criteria was considered as non-serious. The patient did not receive any treatment for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
26 2021-03-10 dizziness Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had ... Read more
Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.
26 2021-03-10 pain in extremity Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patien... Read more
Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not available/provided to reporter at the time of report completion), via an unspecified route of administration from 22Dec2020 to 22Dec2020 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks was unknown. Covid prior vaccination and Covid tested post vaccination was unknown. The patient experienced very sore arm (pain in extremity) (non-serious) on 23Dec2020. This report is for the first vaccination only. I will put a second report in for adverse events reported for the second vaccination as well. The outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.
26 2021-03-14 pain chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consume... Read more
chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consumer. A 26-year-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 13Jan2021 at single dose for an Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose on 22Dec2020 for Covid-19 immunisation. The patient stated eleven hours after dose, person woke up with chills, body aches, and presumed fever (temp not taken at that time). Continued throughout the day. Next morning, temp taken by person and was 99. Still slightly chilled at the time. Estimating adverse event start date as not sure if it was on 13 or 14Jan. Only that adverse events started 11 hours after dose. The patient underwent lab tests and procedures which included body temperature: 99 on. The outcome of the events for chills and presumed fever was not recovered and for body aches was recovered on an unspecified date of 2021. Information about Lot/Batch has been requested.
27 2020-12-31 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for great... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours
27 2020-12-31 pain, pain in extremity Started to have soreness in the left arm the day after with body aches the next day (12/30). Then de... Read more
Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.
27 2021-01-01 dizziness Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and d... Read more
Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and dizziness. She No epinephrine was given and she was able to walk out after ten minutes of sitting with head held forward.
27 2021-01-02 dizziness Pt reports she has had an increased heart rate in the 110-120s for the past three days after receivi... Read more
Pt reports she has had an increased heart rate in the 110-120s for the past three days after receiving the COVID19 vaccination. Pt reports increased dizziness today, nausea, and in the past hour some chest tightness. Pt also reported recent travel to and from out of town, about 14 hours travel time in the past week and half. Pt given fluids, ruled out for illness and PE. Pt improved with fluids.
27 2021-01-03 dizziness After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better... Read more
After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.
27 2021-01-03 feeling hot, feeling hot Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burni... Read more
Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burning up" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved
27 2021-01-03 pain Fever, Chills, body aches for 96 hours after receving vaccine
27 2021-01-03 numbness I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm. Immediately at the ... Read more
I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm. Immediately at the time of the administration, I noticed numbness in my left pinky & ring finger that extended to my elbow. I figured they may have ?hit a nerve? so I called my PCP afterward. My PCP advised me to take Ibuprofen 600mg and to call the next day with any new or worsening symptoms. When I woke up the next day, I noticed numbness in both of my feet (with continued numbness in my left forearm). I had a visit with my PCP where I had a normal neurological exam except for the paresthesias. I did not sleep well the night before, so I was sent home with a medication to assist in sleeping and to observe over the holidays to see if my condition improved. Otherwise, my PCP would order more testing. Monday after the holidays (12/28/2020), my symptoms didn?t improve. I noticed that I have constant numbness in bilateral hands and feet with periodic episodes where my entire left leg and then my entire right arm had tingling/numbness/crawling sensation. I had some fasting labs done on 12/29/2020: CBC, CMP, CRP, Sed Rate, TSH, Magnesium, eGFR were all within normal limits. My B12 was slightly low at 210 (normal levels are listed as 211-911). I received a B12 injection that same day and started OTC B12 supplements. I am currently waiting on the referral to go through an EMG. Since receiving my B12 injection, I noticed a few more episodes over the New Year holiday break. From 12/31/20-01/02/21, I had this tingling/unpleasant sensation episode on my whole right side. My entire arm and leg were being affected; the episode was constant throughout most of the day with a few moments of relief with hot showers/heating blanket. No weakness noted. I currently have a message out to my PCP to update.
27 2021-01-03 lightheadedness, feeling hot, dizziness Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection. She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness. Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious. Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious. Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness. Patient had tachycardia and self-reported palpitations. Received IV fluids and observation on telemetry with no rhythm disturbance. Patient discharged 1428 on 12/24. On 12/29, patient returned to ED at 0326 for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation. Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
27 2021-01-03 dizziness lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine... Read more
lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine.
27 2021-01-03 tingling, pain, tingling, pain received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakene... Read more
received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00
27 2021-01-04 dizziness, lightheadedness, weakness, pain 12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Rep... Read more
12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.
27 2021-01-04 pain Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was test... Read more
Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.
27 2021-01-04 pain Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fi... Read more
Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fine and it all came back.
27 2021-01-04 feeling cold I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild... Read more
I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.
27 2021-01-04 feeling hot Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes ... Read more
Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes in total.
27 2021-01-04 pain, dizziness, weakness Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday ... Read more
Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches
27 2021-01-04 pain in extremity Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female pati... Read more
Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 28Dec2020 at 08:30 AM at a single dose; and the first dose via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination, had no known allergies, and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient experienced sore arm on 28Dec2020 at 09:00. The patient received no treatment for the event. The outcome of the event was unknown.
27 2021-01-05 pain 12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone cr... Read more
12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.
27 2021-01-05 tremor Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly as... Read more
Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.
27 2021-01-05 dizziness Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a c... Read more
Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/4130421), via an unspecified route of administration on 29Dec2020 10:00 in left arm at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included linaclotide (LINZESS) and a combination birth control pill both received within 2 weeks of vaccination. On 29Dec2020 at 10:00 PM (22:00), the patient experienced chills, nausea, feeling lightheaded and cervical lymphadenopathy. The symptoms were severe enough that the patient needed to leave work in the middle of her shift (primarily due to the lightheadedness). The patient tried drinking juice, water, etc but it kept getting worse so after a few hours the patient decided she needed to leave work. The patient did not received treatment for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
27 2021-01-05 migraine Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer ... Read more
Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.
27 2021-01-05 pain in extremity, pain EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include T... Read more
EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.
27 2021-01-05 pain High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated wi... Read more
High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated with Tylenol and ibuprofen, fluids, and cool rags. Symptoms began 1/4/21 around 8pm with a fever of 102 that increased through the night to 104 after vomiting.
27 2021-01-05 weakness, dizziness, tremor Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted... Read more
Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.
27 2021-01-05 weakness, vertigo Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vac... Read more
Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.
27 2021-01-05 dizziness, weakness WEAKNESS, HEAVY FEELING , FEELING LIKE GOING TO PASS OUT, CHEST HEAVINESS
27 2021-01-06 dizziness 15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest... Read more
15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest 1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom
27 2021-01-06 pain After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to ge... Read more
After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to get tested. Since then I returned to work on 1/4 still can't smell/taste .I have to wait 90 days until I receive my 2nd dose Covid vaccine.
27 2021-01-06 tingling, pain Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days la... Read more
Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.
27 2021-01-06 pain Day 6 post shot: low grade fever, Body Aches, Chills, Tiredness, Headache and nausea
27 2021-01-06 dizziness Dizziness, blurred vision, nausea. Taken to ED from vax site. Given IVF, Zofran inj.
27 2021-01-06 pain Fatigue, Headache, Body aches for 1 day, helped with 1 gm of tylenol
27 2021-01-06 pain Headache, Temperature, Body Aches, Chills, Sweaty
27 2021-01-06 pain Nausea/vomiting, fevers, painful supraclavicular lymphadenopathy, body aches
27 2021-01-06 vertigo Pt experienced vertigo, spinning and headaches after vaccine administration
27 2021-01-06 pain Roughly 10 hours after receiving 2nd dose of the vaccine, woke with chills and severe body aches. To... Read more
Roughly 10 hours after receiving 2nd dose of the vaccine, woke with chills and severe body aches. Took 400 mg ibuprofen and put on additional layers and was eventually able to sleep for a couple more hours. Chills improved during mid-day, but body aches remained. Approaching 22-24 hours post vaccine, chills and body aches worsened. Took oral temperature in the evening which read 100.5 F. Took additional 400 mg ibuprofen and fluctuated between hot and cold for the rest of the evening. Awoke the next day(~36 hours post dose) and fever was gone but mild chills and body aches remained. Symptoms virtually gone by early afternoon (slightly before 48 hours after dose).
27 2021-01-06 pain Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back,... Read more
Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021
27 2021-01-06 pain chills, nausea, body aches, headache, fever
27 2021-01-06 pain chills/sweats, head ache, body ache, joint pain, fatigue
27 2021-01-07 dizziness 12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lighthea... Read more
12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lightheaded. Intermittent chills. Symptoms lasted 20 minutes. 12/23 24 hour post vaccine, symptoms returned. myalgia. Temp was higher then normal baseline; 99.4. 12/24 still had dizziness. called employee health; mild / moderate reaction to vaccine. Tylenol. Dizziness resolved. 12/25 symptoms resolved. Following Monday, afternoon, felt extremely fatigued. Touched base with COVID committee; UPMC/advised to get titers checked.
27 2021-01-07 dizziness, balance disorder Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomit... Read more
Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.
27 2021-01-07 pain, pain in extremity Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. ... Read more
Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.
27 2021-01-07 pain Body Aches, Chills, Vomiting, Extreme tiredness, Swelling at the injection site.
27 2021-01-07 pain, pain in extremity Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: i... Read more
Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches
27 2021-01-07 dizziness Dizziness elevated heart rate HA . Dizziness and elevated HR resolved later per the patient nad did ... Read more
Dizziness elevated heart rate HA . Dizziness and elevated HR resolved later per the patient nad did not feel like her MS
27 2021-01-07 pain Fatigue; achy; chills; This is a spontaneous report from a contactable other hcp (patient). A 27-yea... Read more
Fatigue; achy; chills; This is a spontaneous report from a contactable other hcp (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 04Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included known allergies to shellfish. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced fatigue, achy, chills, all on 05Jan2021 01:15. No treatment received for the adverse events. This a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
27 2021-01-07 pain Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches ... Read more
Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches as well
27 2021-01-07 dizziness Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I ... Read more
Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I do have pots but have been fully function without any currently symptoms of that)
27 2021-01-07 pain Head Ache, body aches, up all night
27 2021-01-07 pain Headache, body aches, up all night.
27 2021-01-07 tremor Hives, Redness, itchy, leg tremors, nervous 25 mg Benadryl PO administered
27 2021-01-07 pain I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was develop... Read more
I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.
27 2021-01-07 pain Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms... Read more
Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms particularly reduced with ibuprofen 600 mg
27 2021-01-07 weakness lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, pai... Read more
lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.
27 2021-01-08 tenderness I woke up the morning after my shot and I had some pain around my left clavicle when putting pressur... Read more
I woke up the morning after my shot and I had some pain around my left clavicle when putting pressure on it (turning in bed, etc. ) and I felt around and there was a small lump. Seems like a swollen lymph node. Today (2 days later), the area is more tender and a little larger upon palpation.
27 2021-01-08 pain Mild body aches with moderate to severe body chills from 9pm until 5am the evening of the shot. Pati... Read more
Mild body aches with moderate to severe body chills from 9pm until 5am the evening of the shot. Patient was ?freezing? despite multiple thick layers of clothing and bed linens. Unclear if there was a fever involved - temperature was never taken at home during the event.
27 2021-01-08 dizziness Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the ... Read more
Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.
27 2021-01-08 pain, dizziness NauseaVomiting Aggravation of POTS, dizziness, fever, nausea, muscle aches and pain Narrative:
27 2021-01-08 pain Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. Thi... Read more
Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. This lasted till about 2am. Finally fell asleep and woke up at 8am very sore but much better. Around 3:30pm I started again with the same severe chills, fever, body aches and now nausea. Woke up in the middle of the night drenched in sweat. The following morning I woke up around 8am again with horrible mid/lower bilateral back pain. This lasted till about 1pm. It?s not 9pm and all symptoms have subsided. I feel hopeful, thanks for all you do!
27 2021-01-08 weakness chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection ... Read more
chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection
27 2021-01-09 pain Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/napr... Read more
Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/naproxen
27 2021-01-09 feeling hot Patient complained of feeling hot, flushed and nausea.
27 2021-01-10 tremor, numbness, tingling 14 minutes post injection, patient laid head on table and started shaking. Complained of severe head... Read more
14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.
27 2021-01-10 pain 24 hours of low grade fever ranging 99.6 -100.8, chills, body aches, fatigue. Symptoms lasted about ... Read more
24 hours of low grade fever ranging 99.6 -100.8, chills, body aches, fatigue. Symptoms lasted about 24 hours. Treated with Tylenol and ibuprofen. Fine 48 hours after vaccine.
27 2021-01-10 pain Fatigue, body aches, diarrhea
27 2021-01-10 pain, weakness Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain a... Read more
Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***
27 2021-01-10 weakness, pain I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended... Read more
I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.
27 2021-01-10 migraine, pain Migraine, body aches, chills, nausea beginning at 0300 the next day after receiving vaccine
27 2021-01-10 pain in extremity, pain Nausea, fatigue, left arm pain that sometimes shoots up my shoulder
27 2021-01-10 numbness, weakness, feeling hot Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weaknes... Read more
Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination
27 2021-01-10 numbness numbness in toes itchy arm hurts face swelling all over swelling of the body
27 2021-01-10 pain severe body aches for about 36 hours
27 2021-01-10 tremor she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, hea... Read more
she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, headache, shaky, and vomiting. She reports 1/9 that it is now gone (lasted about 24 hours).
27 2021-01-11 dizziness At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep deliri... Read more
At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep delirious, light headed, heart was racing, diarrhea, and felt like I was falling in and out of almost passing out, hot flashes, couldn't think straight. It wasa very scary experience for me. This lasted about 15 or 20 minutes I'm guessing (hard to say for sure because I was too worked up to watch the clock) but I ended up making myself fall back asleep. The next day January 8th I had diarrhea multiple times in theafternoon and felt strange, somewhat lightheaded and some what felt like anxiety.
27 2021-01-11 pain Body aches, Fever 102
27 2021-01-11 pain Body aches, headache, low grade fever
27 2021-01-11 tingling Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 min... Read more
Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 minutes. No decrease or increase in feeling. She called her mother to come and pick her up. She was escorted out of the clinic walking.
27 2021-01-11 tingling Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain... Read more
Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog
27 2021-01-11 vertigo The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The... Read more
The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; This is a spontaneous report from a non-contactable other healthcare professional (hcp). A 27-year-old female patient receive first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EL0140), intramuscularly on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There is unknown if any other vaccine received in four weeks. The patient experienced the day after vaccine administration, patient was still experiencing vertigo, spinning and headache, all on 31Dec2020 the day after vaccine administration. The outcome of events was unknown. This is a non-serious report. It's unknown if patient was diagnosed with COVID-19 or tested for COVID-19 since the vaccination. The adverse did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
27 2021-01-11 pain body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection si... Read more
body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.
27 2021-01-11 dizziness, pain immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness sh... Read more
immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says. on questioning if BP was checked, she said BP was not checked. Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal. Headaches she also reported arm aching at this vaccination site. initially said in 1/2 hour later she says 2 hours. She looked at the vaccination site on her arm for first time 8 hours after this vaccination. Found redness and blisters first time treated with diphenhydramine 5 mg. barely move arm next day. swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician
27 2021-01-11 pain patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 1... Read more
patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 11 pm and included: fever of 100.4 degrees Fahrenheit-relieved with tylenol, headache, body/muscle aches, chills, sore throat
27 2021-01-12 pain Fever of 100.2, body aches, headache
27 2021-01-12 pain Fever, chills, body aches, headache, nausea
27 2021-01-12 pain Fever, chills, headache, body aches 12hrs after vaccine administration. Diarrhea 18hrs after admini... Read more
Fever, chills, headache, body aches 12hrs after vaccine administration. Diarrhea 18hrs after administration. Symptoms lasted 24hrs.
27 2021-01-12 pain, dizziness, tremor Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This... Read more
Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
27 2021-01-12 pain HEADACHE, FEVER, BODY ACHES, CHILLS.
27 2021-01-12 dizziness Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, ... Read more
Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.
27 2021-01-12 dizziness Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headach... Read more
Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; This is a spontaneous report from a contactable health care professional. A 27-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, intramuscular, in left arm on 15Dec2020 at 18:45 (at the age of 27 years-old), as a single dose for COVID-19 immunization. The patient received the vaccination at a hospital. There was no medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported if the patient took any other medications in the 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Dec2020, the patient experienced an instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea (N/V/D), fatigue, and a fever of 100.6. The patient was not hospitalized for the reported events and no treatment was given. The clinical outcome of the events of instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea, fatigue, and a fever of 100.6 was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
27 2021-01-12 pain Low grade fever (99.9), body aches, headache, fatigue. Took Tylenol. Symptoms lasted around 8 hour... Read more
Low grade fever (99.9), body aches, headache, fatigue. Took Tylenol. Symptoms lasted around 8 hours. Headache persisted all day.
27 2021-01-12 dizziness Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fati... Read more
Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.
27 2021-01-12 pain in extremity, weakness, pain Pain in arm, difficulty moving arm, fever, chills, weakness, fatigue
27 2021-01-12 pain in extremity Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle ach... Read more
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle aches, arm pain and chills.
27 2021-01-12 dizziness, numbness Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt ... Read more
Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt cold, cold raindrops felt scalding, trouble thermoregulating) couldn't tell where arms were, dizziness, passed out.
27 2021-01-12 dizziness Strong headache, muscle pain, fatigue, dizziness
27 2021-01-12 pain This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccin... Read more
This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccine at around 3, and didn't have any immediate reaction. I have an exercise bike at home, and tried to work out but had to stop after only half an hour of very low effort biking because I couldn't get a deep breathe. usually I can bike for an hour at high intensity no problem and have never had to stop because I felt like I couldn't breathe. I woke up in the middle of the night feeling achy and unwell. When I woke up in the morning I was extremely fatigued and my eyes were itchy and puffy.
27 2021-01-12 pain Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection sit... Read more
Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.
27 2021-01-12 numbness, feeling hot left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on n... Read more
left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
27 2021-01-12 pain muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains t... Read more
muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving. Information about lot/batch number has been requested.
27 2021-01-12 pain in extremity sore arm
27 2021-01-13 pain After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm s... Read more
After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm soreness at the injection site. Later in the day, I experienced fatigue, which progressed to body chills and aches. Overnight, I developed a fever of 101.5 F. Fever was managed with ibuprofen taken throughout the following day, 1/13/21. On 1/13/21 at night, I had another fever of 101.6 F but did not taken any antipyretics before bed. On the morning 1/14/21 body aches, body chills, and fevers were resolved without antipyretics. Arm soreness still present on 1/14/21.
27 2021-01-13 pain Body Aches, Headaches
27 2021-01-13 pain Chills, headache, general ache for 1 day. Lymphadenopathy for 3 days.
27 2021-01-13 pain Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable ph... Read more
Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable pharmacist, the patient. This 27-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), dose 2, single dose via an unspecified route of administration in the right arm on 04Jan2021 at 06:15 PM (at the age of 27 years-old) for COVID-19 vaccination. There was no relevant medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), single dose, dose 1 in the left arm on 17Dec2020 at 12:00 PM and had injection site pain. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oral contraceptives. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 04:00 AM, the patient had chills, fever, body aches, headache, fatigue. The events were reported as non-serious. The onset was roughly 10 hours after dose. All symptoms apart from fatigue resolved between 36 and 48 hours after dose. The patient was treated for fever and muscle aches with over the counter (OTC) ibuprofen. The clinical outcome of chills, fever, body aches, headache was recovering and not recovered from fatigue. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
27 2021-01-13 pain Fatigue, body aches, nausea, chills. Improving.
27 2021-01-13 pain Fever 99.8F, body aches, fatigue
27 2021-01-13 pain Fever, bodyaches, chills, headache and fatigue
27 2021-01-13 dizziness Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry m... Read more
Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.
27 2021-01-13 weakness, dizziness Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (dat... Read more
Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).
27 2021-01-13 migraine I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, ... Read more
I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.
27 2021-01-13 pain in extremity Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my... Read more
Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain
27 2021-01-13 dizziness Systemic: Light headedness and dizziness-Medium
27 2021-01-13 dizziness When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second d... Read more
When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second dose I had the vaccine injected and then I got up and walked to the monitoring room where we sit for 15 minutes. Immediately upon sitting down in that room I felt very woozy, lightheaded, and my heart was beating out of my chest. I checked my pulse on my smart watch and it was in the 80s but my resting HR is normally in the 60s or 70s. I got nervous at that point so I took some deep breaths and tried to relax and my symptoms improved within a minute. I sat for the remainder of the monitoring period and right at my 15 minute mark all of my symptoms returned. HR in the 100s, lightheaded like I was going to pass out, chest heaviness, and shortness of breath. I alerted the nurse in the monitoring room and she took my BP and HR and they have me a bottle of water. My throat felt a little weird too and I was worried that it was starting to close up, but I was able to swallow water normally. I remained in the monitoring room for about 15 more minutes and at that point my symptoms mostly resolved and I felt well enough to leave. For the next approx 48 hours I have had some mild- moderate chest heaviness. More worse in the initial 24-36 hours after the vaccination.
27 2021-01-13 pain in extremity felt numbness at the injection site; moderate upper arm pain from just below the injection site to a... Read more
felt numbness at the injection site; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; Throughout the day (Dated) it became increasingly difficult to turn my head in any direction and is very painful to move it to the left; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration from 06Jan2021 14:15 (reported as "02:15 PM") at single dose on the left arm as COVID vaccine. The COVID-19 vaccine was administered in a workplace clinic. Medical history included gastrooesophageal reflux disease (GERD), Acid Reflux Disease, Pseudo Tumor and known allergies reported as "Known allergies: Sulfate Drug, Pertussis". The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient reported that directly after the shot, she felt numbness at the injection site and stated "I realize this is normal and the shot was given properly and painlessly in the upper left arm) at approximately 2 am (12 hours after receiving the vaccine)". Patient woke up with moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line. Throughout the day on 07Jan2021, it became increasingly difficult to turn her head in any direction and was very painful to move it to the left. The events occurred on 07Jan2021 -2:00 AM. Events were assessed as non-serious. No treatment was received for the events. No Covid prior vaccination. The patient was not tested for COVID after/post vaccination. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
27 2021-01-13 pain in extremity redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; ... Read more
redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on 07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
27 2021-01-14 numbness After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could n... Read more
After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl
27 2021-01-14 pain Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; ... Read more
Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. No known allergies. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for birth control. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 21Dec2020 08:00 at a single dose on left arm for COVID-19 immunization. The patient experienced body aches, chills, headache, nausea - emesis x1 on 08Jan2021 02:00. No treatment received for adverse event. The outcome of the events was recovering. The events were assessed as non-serious. Facility type vaccine was Hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
27 2021-01-14 pain Body aches, chills, joint pain, night sweats
27 2021-01-14 numbness, pain Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pa... Read more
Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better
27 2021-01-14 pain Patient presented to emergency department with nausea, diarrhea, fatigue, and body aches. Patient wa... Read more
Patient presented to emergency department with nausea, diarrhea, fatigue, and body aches. Patient was given phenergan with resolution of symptoms. Patient was discharged home in stable condition
27 2021-01-14 tremor, weakness Seizure like reaction after COVID-19 vaccine, experienced weakness and shortness of breath.
27 2021-01-14 pain Shortly after the dose, I had fatigue Over the next 12-36 hours, I experienced full body aches, extr... Read more
Shortly after the dose, I had fatigue Over the next 12-36 hours, I experienced full body aches, extreme fatigue, fever and chills Had to call in sick for work It resolved after 48 hours
27 2021-01-14 pain in extremity arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contact... Read more
arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1618; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 12:15, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies (NKA). Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), naproxen sodium (NAPROSYN). It was unknown if the patient is pregnant at the of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 07Jan2021, at 13:00, the patient experienced headache (minor) day of. The patient experienced arm soreness (minor) day after (08Jan2021). The patient received naproxen as treatment for the events. Outcome of the events was recovered.
27 2021-01-14 pain chills, headache, fatigue, generalized aches, intermittent nausea (no emesis) -all symptoms lasting... Read more
chills, headache, fatigue, generalized aches, intermittent nausea (no emesis) -all symptoms lasting around 24 hours at this time
27 2021-01-15 pain in extremity I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lympha... Read more
I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lymphadenopathy on the same arm as my injection. No palpable lymph nodes on affected armpit. Mild discomfort with palpating the edema in the affected armpit. Took 600mg ibuprofen. Swelling continued into Monday 1/11/21, but had decreased in size
27 2021-01-15 pain Stomach pain, chills, low grade fever, body aches, joint pains, headache, hot flashes, fatigue
27 2021-01-15 numbness arm and leg numbness
27 2021-01-16 pain Around 6:00pm I started getting very severe upper abdominal cramps, and a headache. I was unable to ... Read more
Around 6:00pm I started getting very severe upper abdominal cramps, and a headache. I was unable to do anything except lay down. Its currently 12:12am and I still have both symptoms.
27 2021-01-16 dizziness, feeling hot Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous a... Read more
Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.
27 2021-01-16 pain headache, chills, fever, body aches/ muscle soreness after 2nd dose
27 2021-01-17 dizziness Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint... Read more
Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint pain - ankles, knees, hips
27 2021-01-17 tingling, pain in extremity Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my ... Read more
Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.
27 2021-01-17 pain, lethargy profound headache; resembling meningitis: could not turn neck from side to side; resembling meningit... Read more
profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
27 2021-01-18 pain Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to ... Read more
Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
27 2021-01-18 pain in extremity tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did no... Read more
tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; This is a spontaneous report from a contactable consumer (patient herself). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. EH9899 and expiry date Mar2021), via an unspecified route of administration on 05Jan2021 on her left arm at a single dose for covid-19 immunization. Medical history included leg pain. There was no reported concomitant medications. On an unspecified date, patient received COVID vaccine. She stated that she was symptomatic during the vaccine and somewhere after confirmed that she was COVID-positive. She wanted to know if there are any health concerns with getting the vaccine while COVID positive. She added that this was her first dose. she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst but did not think that it was a symptom. She stated that she does not recall the first time ever that she had leg pain but stated that the leg pain was really bad the night before the vaccine. She added that she was isolated until 14Jan2021. Outcome of the events drug ineffective, COVID-19 virus test positive and leg pain were unknown.; Sender's Comments: Leg pain is considered intercurrent and unrelated to suspect BNT162B2.
27 2021-01-19 feeling hot, dizziness 1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning ... Read more
1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride
27 2021-01-19 pain in extremity Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swel... Read more
Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swelling of lymph nodes in throat, armpit, and groin. Swelling in lymph nodes of arm that received vaccine was so severe that I could not let my arm rest down by my side without throbbing pain. Pain went away after about 48-72 hours but swelling persisted for 1 week.
27 2021-01-19 pain Chills, body aches, runny nose, Headache, Temperature 99.4, lymph node swollen and tinnitus.
27 2021-01-19 pain Continuous severe headache, body ache, swollen lymph nodes, low grade fever (97.7 F)
27 2021-01-19 numbness Facial Numbness
27 2021-01-19 pain Fever, body aches, fatigue, sensitive to touch, headache
27 2021-01-19 pain, pain in extremity I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine.... Read more
I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine. My symptoms lasted about 12 hours and I feel completely fine now.
27 2021-01-19 dizziness Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizz... Read more
Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%
27 2021-01-19 dizziness Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.... Read more
Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.
27 2021-01-20 pain She is 11 weeks pregnant EE received 2nd covid vaccine on 1/19 at 0727 and began having s/s 1/20 at... Read more
She is 11 weeks pregnant EE received 2nd covid vaccine on 1/19 at 0727 and began having s/s 1/20 at 1400: HA, body aches, chills, fatigue.
27 2021-01-21 tremor Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), m... Read more
Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess
27 2021-01-21 weakness, numbness, tingling Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING... Read more
Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event "Nerve Injury" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event "Nerve Injury" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.
27 2021-01-25 pain in extremity, pain Body aches, low grade fever, nausea, vomiting, diarrhea, HA, arm soreness
27 2021-01-25 pain Chills, full body aches, headache, upset stomach
27 2021-01-25 pain Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthca... Read more
Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 and second dose, via an unspecified route of administration on 13Jan2021 (lot/batch number and expiration date were unknown); both at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included COVID-19 on an unknown date prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had not tested for Covid post vaccination. On 24Dec2020, the patient experienced fatigue, body aches, and low grade fever. The patient did not receive any treatment for the events. The patient recovered from all the events on an unspecified date. Information on the lot/batch number has been requested.
27 2021-01-26 pain After my shot I felt fatigued and body aches I slept most of the day and hydrated myself. The next d... Read more
After my shot I felt fatigued and body aches I slept most of the day and hydrated myself. The next day when I got up I had full blown sinus problems, headache, congestion, cough (progressed over a couple of days), throat and nasal pain/soreness. I felt that way until about the 01/02 or 01/03 and I was on antibiotics and fluids during this time period.
27 2021-01-26 dizziness Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at i... Read more
Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
27 2021-01-26 dizziness Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with sym... Read more
Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with symptoms occurring on and off during that period. At 1025 she felt flushed again with report of scratchy throat. No distress noted. Oxygen sats 100%. No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.
27 2021-01-26 pain I had a cough for two days that got worse, nasal congestion & body aches.
27 2021-01-26 numbness I had sudden onset moderate left facial pain then mild weakness and numbness on the left side of my ... Read more
I had sudden onset moderate left facial pain then mild weakness and numbness on the left side of my face. It?s slightly better now but has not resolved. It started about 3 hours after my vaccine. No other symptoms.
27 2021-01-26 pain in extremity Severe L arm pain starting the day of injection. Additionally, L arm weakness. Worse pain and weakne... Read more
Severe L arm pain starting the day of injection. Additionally, L arm weakness. Worse pain and weakness for the first week after injection, but pain and weakness still present at the time of submission (>2 weeks from injection)
27 2021-01-26 pain in extremity Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pai... Read more
Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pain/ache for 24 hours straight.
27 2021-01-26 pain fever, body aches, chills, nausea
27 2021-01-28 pain Chills, body aches, fever, fatigue, headache; 48 hrs duration; treated withTylenol 650 mg alternated... Read more
Chills, body aches, fever, fatigue, headache; 48 hrs duration; treated withTylenol 650 mg alternated with Ibuprofen 1000mg
27 2021-01-28 feeling hot, feeling cold, pain, tremor Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore thro... Read more
Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore throat, cough, congestion, and sinus pressure.
27 2021-01-28 tingling, feeling cold Staff described feeling tingles and coldness in extremities especially arms. Also became tachycardic... Read more
Staff described feeling tingles and coldness in extremities especially arms. Also became tachycardic. Emergency service called and epi-pen administered per instruction. Staff left via ambulance for evaluation. Appeared stable at time of departure.
27 2021-01-31 dizziness, tremor Headache right after vaccine was administered. Approximately 40min after vaccine was administered I... Read more
Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.
27 2021-02-17 feeling hot fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling ... Read more
fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.
27 2021-02-21 dizziness Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female p... Read more
Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) intramuscularly in the left upper arm on 13Jan2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 13Jan2021, the patient was dizzy to the point of needing to lay down. The patient queried whether she should take the second dose. The patient did not receive treatment for this event, nor did the event require a visit to the emergency room or doctor's office. The clinical outcome of "dizzy" was resolved on 24Jan2021.
27 2021-02-21 dizziness Pt stated she has POTS syndrome and was feeling dizzy. Pt given 2 bottles of gatorade and monitored ... Read more
Pt stated she has POTS syndrome and was feeling dizzy. Pt given 2 bottles of gatorade and monitored for additional 15 minutes. Pt tolerated fluids well and stated she felt better and was ready to leave. Walked pt to front door where fiance was meeting her. Pt denied any additional symptoms and stated if her symptom worsened she would go to the emergency room.
27 2021-02-21 lethargy Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 2... Read more
Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.
27 2021-02-22 pain A few days after the vaccine I woke up to the lymph nodes in both sides of my neck swollen with the ... Read more
A few days after the vaccine I woke up to the lymph nodes in both sides of my neck swollen with the left being more affected than the right. On 1/13 my PCP advised rest, ibuprophen and tylenol to help with the pain. 1/14 I had to call out to work because I just couldnt move my neck from left to right.
27 2021-02-22 numbness After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left finger... Read more
After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.
27 2021-02-22 pain Patient indicates that after 5 days after administration started feeling headaches, body aches. Test... Read more
Patient indicates that after 5 days after administration started feeling headaches, body aches. Test results indicate Positive to COVID-19.
27 2021-02-25 feeling cold, facial paralysis Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freez... Read more
Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.
27 2021-02-28 pain Sore arm where injected within an hour or so, became more sore over the next day followed by chills,... Read more
Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.
27 2021-02-28 pain in extremity, pain body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable cons... Read more
body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
27 2021-03-02 dizziness Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-ol... Read more
Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, Headache, Lightheaded; all on 31Jan2021 at 05:00 AM. No treatment was received for the events.
27 2021-03-02 feeling hot My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke ou... Read more
My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
27 2021-03-03 pain 101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; he... Read more
101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
27 2021-03-09 dizziness, pain Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient).... Read more
Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose bnt162b2 (reported as PFIZER COVID 19 VACCINE, lot number: unknown, Lot number wasn't given when receiving shot), via an unspecified route of administration in right arm on 05Feb2021 07:45 AM at single dose for COVID-19 immunisation. The patient did not have other medical history or known allergies. There were no concomitant medications (no other medications in two weeks). The patient was not pregnant. The patient previously received first dose bnt162b2 (reported as PFIZER COVID 19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 07:45 AM at single dose for COVID-19 immunisation. The patient experienced Fever, chills, dizziness, aches on 05Feb2021 07:15 PM. AE resulted in 'None of the above'. The patient did not receive treatment for the events. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination, type was Nasal Swab and result was negative. The outcome of the event was recovering. Information on the Lot/Batch number has been requested.
27 2021-03-09 dizziness received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and ... Read more
received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.
27 2021-03-15 pain in extremity, dizziness Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consume... Read more
Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information was provided.
27 2021-03-17 tingling Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less tha... Read more
Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.
27 2021-03-18 dizziness Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in... Read more
Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) to reported events cannot totally be excluded.
28 2020-12-31 dizziness From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had ... Read more
From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).
28 2020-12-31 pain Sudden onsite 6pm the next day of fever, chills, sweats, headache, body aches
28 2020-12-31 difficulty speaking tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. ... Read more
tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.
28 2021-01-01 pain 31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injectio... Read more
31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.
28 2021-01-01 pain Fever, chills, headache, body aches
28 2021-01-03 tingling AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ... Read more
AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ears. She denied any flushing, dizziness, headaches, cough, sob, numbness sensation around her mouth, chest discomfort
28 2021-01-03 dizziness Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated fe... Read more
Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet. Went to ED, per patient did not receive any medications, just had an EKG.
28 2021-01-03 tingling Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain.... Read more
Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-01-03 tingling Patient developed SOB, wheezing, tongue swelling, facial tingling.
28 2021-01-03 pain, feeling hot She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate e... Read more
She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.
28 2021-01-03 pain headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continu... Read more
headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continued to take Tylenol PRN with relief.
28 2021-01-03 dizziness within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushe... Read more
within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.
28 2021-01-04 pain Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache... Read more
Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.
28 2021-01-04 pain Chills, Body Aches, Temp 99.3, fatigue resolved within 48 hours from onset
28 2021-01-04 pain Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a cont... Read more
Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 26Dec2020 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. Medical history included depression, chronic pain, obesity. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), melatonin, fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen; all for unknown indications from unknown dates and unknown if ongoing. The patient previously took cefdinir (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 5:00, the patient experienced chills and body aches for hours. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills and body aches for hours was not resolved. Information on the lot/batch number has been requested.
28 2021-01-04 dizziness, feeling hot Day of administration around 2100 I started feeling a little off, got a little bit of a headache and... Read more
Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm (99.5) and a mild headache. Will keep an eye on any other adverse reactions.
28 2021-01-04 pain Experienced nausea, fever, chills, and body aches
28 2021-01-04 pain in extremity Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physi... Read more
Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
28 2021-01-04 dizziness, restlessness, tremor Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous r... Read more
Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.
28 2021-01-04 numbness Numbness in right cheek of face almost immediately after injection.
28 2021-01-04 dizziness, feeling hot Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minu... Read more
Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM
28 2021-01-04 pain fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVI... Read more
fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVID per employee health policy on 12/31 - negative. Rash began 2 days after vaccination. was seen at Urgent care on 1/2/21, given prednisone. Rash worsened, fever broke. seen again 1/3/21 - given kenalog shot. tested for COVID-19 (negative). Rash continues to spread, headache improved but not resolved.
28 2021-01-05 pain in extremity Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a conta... Read more
Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.
28 2021-01-05 pain Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm ... Read more
Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm on same day. 5am on 1/6 severe body aches and temperature of 100.3
28 2021-01-05 pain Chills, body aches, fatigue
28 2021-01-05 pain Had 2nd vaccine at 1pm yesterday (01/05). 8pm started to had fatigue, body ache. At 10pm got worse... Read more
Had 2nd vaccine at 1pm yesterday (01/05). 8pm started to had fatigue, body ache. At 10pm got worse severe headache, fatigue, bodyache, 99-100.6. 10am this morning (01/06). Headache was severe that staff had to take medicine and could not sleep well.
28 2021-01-05 dizziness I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of br... Read more
I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.
28 2021-01-05 dizziness Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06... Read more
Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06 diarrhea
28 2021-01-05 pain swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild... Read more
swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
28 2021-01-06 numbness, tingling After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, sync... Read more
After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.
28 2021-01-06 pain in extremity, pain Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were re... Read more
Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were refractory to ibuprofen and required both ibuprofen and Tylenol to break. The fever and chills continued for 24 hours and the headache/body aches continued for 36 hours, the arm soreness has improved but is ongoing.
28 2021-01-06 pain Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. F... Read more
Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7. Denies any respiratory, ocular, or GI symptoms. Note - injection lot # not available.
28 2021-01-06 dizziness Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and naus... Read more
Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.
28 2021-01-06 dizziness Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be ... Read more
Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport
28 2021-01-06 pain, pain in extremity Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about... Read more
Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about 24 hours and prevented me from performing daily activities or working.
28 2021-01-06 pain, pain in extremity had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included c... Read more
had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.
28 2021-01-07 numbness, feeling cold, tingling 15 minutes post injection had numbness and tingling in left arm, complained of feeling cold, tinglin... Read more
15 minutes post injection had numbness and tingling in left arm, complained of feeling cold, tingling started in her back too. Called for rapid response and patient was transported to ED>
28 2021-01-07 pain About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induc... Read more
About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induced vomiting (unable to keep down water). 12 hours then after these symptoms is when things began to slowly subside. Just ended up missing work for two days.
28 2021-01-07 pain in extremity Chills and 99.7° fever 26 hours after injection. Very painful arm.
28 2021-01-07 dizziness Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcar... Read more
Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment. The outcome of the events was recovering. Information on the lot number has been requested.
28 2021-01-07 dizziness Entered observation as a "30 minute" Observant, r/t her past vaccine (Pfizer first dose). States sh... Read more
Entered observation as a "30 minute" Observant, r/t her past vaccine (Pfizer first dose). States she was dizzy for about 4hrs after 1st vaccination. Onset 45mins, after 1st vaccination. Became dizzy around (1710) while in observation. This nurse and staff assisted pt to bed to lay down in vaccination clinic. Denies SOB, chest pain, or trouble breathing when asked. Currently remains laying down on bed @ present time (1720). Cold compress applied to help alleviate s/s of dizziness. Still voices s/s of dizziness @ 1730. This nurse asked pt if she would like to be sent to ER. Pt voiced she was "ok", and did not want to be sent to ER. Pt called family @ 1730, r/t having a ride home. This nurse insisted to pt that she did not need to drive "herself". Pt, left w/ family @ 1750, voices slight dizziness upon leaving. Transported via w/c by this nurse w/ family. Left observation @ 1750.
28 2021-01-07 pain Fever Chills Body ache
28 2021-01-07 pain in extremity, pain Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection s... Read more
Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
28 2021-01-07 pain First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd CO... Read more
First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.
28 2021-01-07 pain, feeling hot Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling... Read more
Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.
28 2021-01-07 tingling, numbness I have like tingling and it is not really numbness but feels like my hands are asleep; I have like t... Read more
I have like tingling and it is not really numbness but feels like my hands are asleep; I have like tingling and it is not really numbness but feels like my hands are asleep; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on at single dose for preventive measure for Covid. Medical history included postural orthostatic tachycardia syndrome, migraine, cardiac disorder and ventricular tachycardia. Concomitant medication included sertraline hydrochloride (ZOLOFT), topiramate (TROKENDI XR) and nadolol. The patient stated that on 31Dec2020, "I have like tingling and it is not really numbness but feels like my hands are asleep". The patient underwent lab tests and procedures which included weight: 130 lbs on an unspecified date. The outcome of the events was unknown.
28 2021-01-07 feeling hot Patient began experiencing itching at the injection site and then all over her body. She started fee... Read more
Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.
28 2021-01-07 numbness, tingling Patient experienced numbness and tingling around 15min after dose was received.
28 2021-01-07 pain in extremity Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling ... Read more
Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.
28 2021-01-07 lightheadedness, weakness, tingling Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; ... Read more
Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.
28 2021-01-07 pain in extremity, pain The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I... Read more
The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.
28 2021-01-08 pain, dizziness Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild... Read more
Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild and became severe including: headache, dry cough with chest pressure, dizziness/lightheaded, joint pain, body aches, fatigue, and chills. At 5:30 pm I started getting a fever, that started at 100.5 then increased to 103.3 by 8:30 pm. I was also nauseous and vomited once. I was tested the next morning for influenza and COVID and was negative. My fever came back down to 98.8 around 12 pm the next day. Overall, symptoms lasted approximately 30 hours after the vaccine was administered. I was out of work the following day after the vaccine. Now, 2 days after the vaccine I am just mildly fatigued with a dry cough left.
28 2021-01-08 pain in extremity Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 h... Read more
Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 hours after injection and lasting for 2 days Brain fog starting about 6 hours after injection and lasting for 2 days Mild headache starting about 6 hours after injection and lasting for about 4 days
28 2021-01-08 dizziness, vertigo Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabil... Read more
Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).
28 2021-01-09 pain in extremity - Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myal... Read more
- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine
28 2021-01-09 pain in extremity 1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Feve... Read more
1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted
28 2021-01-09 pain 12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-... Read more
12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-10; VOMITING BODY ACHES, HA. WENT TO ER. COULDN'T KEEP ANYTHING DOWN, EVEN MEDICINE. GAVE ZOFRAN, COVID TEST (NEGATIVE) FELT LIKE I WAS KNOCKED OUT. DIDN'T GET OUT OF BED FOR DAY. TEMP GOT UP TO 102. WITH TYLENOL, IBUPROFREN. BODY WAS SORE. THESE SYMPTOMS ARE STILL PRESENT. LINGERING COUGH. 1/1/2021 FEVERS. LASTED 1-2 DAYS. MUNICEX FOR COUGH AS NEEDED. NOT 100% BETTER, MAYBE 95%
28 2021-01-09 pain Fatigue, body aches, headache, low grade fever, arm pain, axillary pain
28 2021-01-09 pain I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am appr... Read more
I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am approximately 6 weeks. About 12 hours after receiving the vaccine I became ill with body aches, chills, nausea, vomiting, general malaise and headache. I was sick until approximately 1530 on 1/10.
28 2021-01-09 pain Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches,... Read more
Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.
28 2021-01-09 weakness Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours aft... Read more
Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot
28 2021-01-09 tingling Systemic itching, systemic tingling, Hypotension, syncope, Bradycardia, injection site swelling
28 2021-01-10 pain in extremity About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grad... Read more
About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)
28 2021-01-10 numbness Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability... Read more
Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability to move all 4 extremities. No difficulty breathing or swallowing. Benedryl 25 mg was administered with no relief. EMS was called, she was transported to the ED and admitted to the hospital for evaluation. She was given Ativan 0.5 mg IV with some mild improvement in symptoms. She has had gradual improvement in her symptoms, now able to move her arms normally. She has persistent weakness and discomfort in both lower extremities and is unable to ambulate without assistance.
28 2021-01-10 pain Body aches, Chills, fatigue.
28 2021-01-10 pain DVT; have pain in same site where DVT is; This is a spontaneous report from a contactable consumer. ... Read more
DVT; have pain in same site where DVT is; This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9291), via an unspecified route of administration in left deltoid on 24Dec2020 10:00 at first single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Caller was calling to report a possible adverse reaction to the Pfizer Covid-19 vaccine. The patient was currently at hospital, she was admitted for deep vein thrombosis (DVT) of left iliac vein, the patient had no past history as to why this would happen, that she is only 28 years old. Received the vaccine on 24Dec2020, the following day she did have pain in same site where DVT was. Took ibuprofen for the pain. The patient was admitted yesterday 04Jan2020 for the DVT, they were currently treating her with Lovenox injections and prescribing dose for discharge is Eliquis. CT scans and three shots of Lovenox for it, doing a doppler of bilateral legs and echocardiogram (echo) of her heart to make sure there is nothing else. The AEs require a visit to emergency room. The patient was asking if she can still get the 2nd dose based off the adverse event she experienced. Outcome of DVT was not recovered, of pain was unknown.
28 2021-01-10 pain Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiv... Read more
Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiving the vaccine. 7x8cm area of erythema, warmth and induration at injection site.
28 2021-01-10 pain in extremity, pain Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30... Read more
Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.
28 2021-01-10 facial paralysis On 01/05/21 at 6:30 A.M. the patient woke up and noticed facial right side quivering. On 01/08/21 t... Read more
On 01/05/21 at 6:30 A.M. the patient woke up and noticed facial right side quivering. On 01/08/21 the patient noticed right side of mouth raised on Sat. 01/09/21 the patient noticed at 4:30 P.M. right side drooping of right mouth corner. The patient went to to the emergency room at Medical Center at 2:30 P.M. The patient was treated with prednisone 20 mg 3 times a day for 5 days.
28 2021-01-10 pain On 1/8/21 (day of injection): Severe bodyaches, fatigue, headache, and mild lymph node tenderness th... Read more
On 1/8/21 (day of injection): Severe bodyaches, fatigue, headache, and mild lymph node tenderness that started 10 hours after the second vaccine dose (booster dose 21 days post initial vaccine administration. ) On 1/11/21: Mild bodyaches, fatigue, headache, and worsening lymph node renderness and visible swelling.
28 2021-01-10 pain Pain at injection site. Fever, body aches, joint aches, headache, fatigue, cough, chest pain.
28 2021-01-10 tenderness Patient reported a tender lump on the left side of neck that was tender to the touch. The lump pres... Read more
Patient reported a tender lump on the left side of neck that was tender to the touch. The lump presented exactly 1 week after the 1st vaccine dose, and it was noticeably swollen. At the time of 2nd dose, the lump was no longer visually noticeable, but could still be felt to the touch. The residual lump is no longer tender to the touch.
28 2021-01-10 dizziness Scratchy throat, dizziness and eventually feeling like her throat is closing in
28 2021-01-10 pain, weakness fever, chills, headache, extreme body aches, nausea, weakness.
28 2021-01-11 pain 12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measur... Read more
12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measured temp 99.4F orally). Body aches occurred at 16 hours. Body aches and sweats and chills continued until hour 36. At hour 33 awoke from sleep with nausea but did not have emesis. At 48 hours all symptoms basically resolved.
28 2021-01-11 pain Chills Body aches Fever (maximum 101.1 degrees F)
28 2021-01-11 pain Fever 100.0 F, body aches,
28 2021-01-11 pain Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received th... Read more
Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.
28 2021-01-11 pain Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS... Read more
Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
28 2021-01-11 pain Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness... Read more
Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes, was tired all day, and "she just did not feel like herself-like she had the flu". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and "she did not feel like herself-like she had the flu" were recovering.
28 2021-01-11 weakness, dizziness Patient became pale, felt weak, dizzy. Vital signs stable, 100% O2 on Room air
28 2021-01-11 pain Received 2nd dose of vaccine at 11:00am. Symptoms started at 9pm: severe body aches, chills, headac... Read more
Received 2nd dose of vaccine at 11:00am. Symptoms started at 9pm: severe body aches, chills, headache, low grade fever of 99.7F. I took motrin and went to bed. Woke up multiple times with chills and sweating. When I woke up: worsened headache and fever of 100F. Will take tylenol and get more rest. Had to call out of work for my midnight shift tonight.
28 2021-01-12 pain Body Aches, Fever, Cough
28 2021-01-12 pain Fever as high as 101.5F and chills starting since 1am, lasting until 10pm. Extreme body and muscle ... Read more
Fever as high as 101.5F and chills starting since 1am, lasting until 10pm. Extreme body and muscle aches. headache that was not alleviated with tylenol or advil.
28 2021-01-12 pain Headache, nausea, body aches, chills, temperature 99F starting around 6pm on the day of vaccination ... Read more
Headache, nausea, body aches, chills, temperature 99F starting around 6pm on the day of vaccination (I received the vaccine at 7:30am). This lasted all night and was resolved by 1pm the following day.
28 2021-01-12 pain in extremity I had a sore arm for two days after vaccine.
28 2021-01-12 pain I noticed on January 12 that my left arm where I received the shot my bones were aching and my joint... Read more
I noticed on January 12 that my left arm where I received the shot my bones were aching and my joints (my shoulder, my elbow, my forearm bones, and all my hand joints) were aching and my hand was slightly swollen. My coworker reported aching joints two days after she received the vaccine. So I?m not sure if my aching joints are related to the vaccine but I?m suspicious they are.
28 2021-01-12 pain I received the first dose of the Pfizer vaccine on December 23 with no complications. The second dos... Read more
I received the first dose of the Pfizer vaccine on December 23 with no complications. The second dose of Pfizer was administered to me on January 11 and I felt okay at first. At 1 am on January 12 I developed severe chills and muscle aches. The chills, body aches, and fatigue persisted all day. Temperature max was 100.3 orally. I continued to take Tylenol every 6 hours and stayed in bed. The next day I felt slightly better, however, still had a headache. I made an appointment with my primary care doctor.
28 2021-01-12 weakness My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles w... Read more
My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.
28 2021-01-12 lethargy Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, genera... Read more
Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, general body weakness, headache, low grade fever 99.4 and taking Tylenol 01/9 still feel lethargic and 1/10 intermittent cough and heaviness when I breathe
28 2021-01-12 dizziness Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 d... Read more
Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 days
28 2021-01-12 pain at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, head... Read more
at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, headache, and felt febrile. I took my temperature twice in the absence of antipyretics and did not have a fever (98.7 and 98.2) but my skin felt hot and painful as it does when I have had a fever in the past. By about 5:00 or around 24 hours post vaccination, all symptoms resolved aside from fatigue and headache, but the headache was less than it was before. I experienced those symptoms for the rest of the evening and woke up this morning feeling completely normal.
28 2021-01-12 pain body aches, lower back pain, headache, chills, fever, nausea
28 2021-01-12 pain, feeling hot, dizziness dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and brok... Read more
dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-01-12 pain, dizziness severe body aches -- started at 07:50 PM 1/12/21 and remained until Tylenol was taken (7 AM 1/13/21)... Read more
severe body aches -- started at 07:50 PM 1/12/21 and remained until Tylenol was taken (7 AM 1/13/21) Fever/chills -- started at 12:30 AM 1/13/21 and remained until Tylenol was taken (7 AM 1/13/21) nausea, dizziness -- started at 6:00 AM 1/13/21 and remained until breakfast was eaten with large glass of cold water
28 2021-01-13 pain 1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills... Read more
1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache. 1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol and chills. 1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough. 1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.
28 2021-01-13 pain in extremity, pain Chills, sweating, throbbing headache, terrible body aches, fatigue, malaise, sore left arm
28 2021-01-13 dizziness Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pa... Read more
Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient). A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021. It is unknown if the patient has been tested for COVID-19 since the second vaccination.
28 2021-01-13 difficulty speaking, speech disorder Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Ben... Read more
Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.
28 2021-01-13 pain in extremity Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after ... Read more
Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after the vaccine.
28 2021-01-13 pain I got the COVID Pfizer vaccine and experienced warmth in my chest with the first vaccine. It went aw... Read more
I got the COVID Pfizer vaccine and experienced warmth in my chest with the first vaccine. It went away after one day and was tolerable. I also developed a lump under my right armpit with the first dose that slowly went away. It was painful, but the pain was tolerable. With the second vaccine, I also got the chest warmth and chest pressure for 2 days. I did not seek help as it was also tolerable. I also developed the lump under my armpit with the 2nd dose, this time I still have it and it is more painful and bigger. I have been taking naproxen for the pain.
28 2021-01-13 pain joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp. A 28-yea... Read more
joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EK5730, intramuscular in the right arm, from 06Jan2021 16:15 to 06Jan2021 16:15 at a single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included BNT162B2 on 17Dec2020. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced joint pain, chills and body aches. The outcome of events was recovering. No treatment was received due to events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
28 2021-01-14 pain Around 7:30 PM on 1/11/2021, patient started to experience fever, diffuse sharp chest pain with body... Read more
Around 7:30 PM on 1/11/2021, patient started to experience fever, diffuse sharp chest pain with body aches, and myalgias. Patient was COVID+ in October 2020. Patient presented to the emergency department and was treated as a sepsis alert and received fluids, ceftriaxone, and ibuprofen with good response. Labs were as follows: Bilirubin and transaminases are normal, D-dimer is normal, serum lactate is normal, EKG is nondiagnostic with prolonged QT, troponin is negative.
28 2021-01-14 pain BODY ACHES, CHILLS, TEMP 101.5, HEADACHE
28 2021-01-14 pain EMPLOYEE REPORTED BEGAN ROUGHLY 12 HOURS FOLLOWING VACCINATION: BODY ACHES, CHILLS, TEMP 101.5, HEA... Read more
EMPLOYEE REPORTED BEGAN ROUGHLY 12 HOURS FOLLOWING VACCINATION: BODY ACHES, CHILLS, TEMP 101.5, HEADACHE. RESOLVED WITHIN 48 HOURS.
28 2021-01-14 dizziness, pain, weakness Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back... Read more
Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
28 2021-01-14 pain Headache, body aches, nausea, chills, fever - 48 hours
28 2021-01-14 pain Headaches and full body aches x 2 days, chills and fever two nights in a row
28 2021-01-14 feeling cold, tremor I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violen... Read more
I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively). Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep. At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills. Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes. Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit. Time of documentation: 11:22 am 1/15/2021
28 2021-01-14 tingling Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin... Read more
Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches
28 2021-01-14 pain MAX TEMP 101.5, CHILLS, BODY ACHES, HEADACHE. ALL RESOLVING WITHIN APPROXIMATELY 48 HOURS.
28 2021-01-14 pain, dizziness Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved naus... Read more
Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved nausea.
28 2021-01-14 pain Symptoms - ? Patient reports around 10:00 PM on 1/13 began with chills, HA, body aches, and fever (T... Read more
Symptoms - ? Patient reports around 10:00 PM on 1/13 began with chills, HA, body aches, and fever (Tmax 100.8), re-checked her temp approx. 2 hrs later, 102.3 and took Tylenol at that time. Thursday: 09:00 fever (Tmax 101) which resolved with tylenol. Patient reporting concerns resolution of fever with Tylenol but once meds wear off, febrile again. Intermittent HA. Friday: woke up around 0700 with + fever (Tmax 101.2) and intermittent HA. Last day of work and shift ? next scheduled shift tonight? Home remedies? - Tylenol/motrin and rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she is scheduled to return to work tonight. Patient educated policy of needing to be fever free for 24 without use of antipyretics prior to returning to work. Patient educated to notify manager and to manage her RTW according to the Hospital Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
28 2021-01-14 tremor, dizziness, pain The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen ... Read more
The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.
28 2021-01-14 feeling hot, pain Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and ... Read more
Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches
28 2021-01-14 pain in extremity headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (p... Read more
headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included Postural orthostatic tachycardia syndrome. Concomitant medication included spironolactone and metoprolol. The patient experienced headache and arm pain on an unspecified date after first dose (reported as "First dose: headache, arm pain"). No treatment received for adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/ batch number has been requested.
28 2021-01-15 dizziness, tremor Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, f... Read more
Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning
28 2021-01-15 weakness Muscle aches, low grade fever of 99.8 F, vomiting, weakness and fatigue.
28 2021-01-15 pain Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the a... Read more
Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the arm of the vaccine site. That night I woke up with moderate body aches and chills and a dull headache, no fever. The next morning, I awoke feeling very fatigued, severe muscle/body aches, headache and chills, still no fever. I slept most of the day. Extra strength Tylenol helped tremendously with the body aches. I was symptom free the morning of 1/15/2021. I was scheduled to work the day after my vaccination and was unable to due to the symptoms described. I had no adverse reactions with my first dose. I am a nursing mother and for the first and second doses, I noticed no side effects or any concerns with my child or milk supply.
28 2021-01-16 migraine, tingling, numbness 2 hours after the administration of the vaccine, the left side of my face briefly started to tingle.... Read more
2 hours after the administration of the vaccine, the left side of my face briefly started to tingle. I slept for 6 hours, and when I woke up, the left side of my face was noticeably having pins and needles. I took 25 mg of oral Benadryl and slept for another 7 hours, and when I woke up, my left arm and leg were experiencing pins and needles. The left side of my face was completely numb, and I felt like that side was being pulled down toward the floor. The left, posterior side of my head felt very tingly, and I had a pounding headache behind the left eye that worsened with light. My boyfriend noticed my smile being different, and after looking in the mirror, I decided to go to ED. They were concerned about Bell's Palsy, but with the extremity involvement, they changed my plan of care to a migraine response from the vaccine. I received an MRI, IV Compazine and IV Toradol. My headache went from a 6/10 to a 2/10 after that treatment, but it came back soon after my discharge.
28 2021-01-16 pain Fever, chills, headache, body aches, left axillary lymph node swelling
28 2021-01-16 numbness Numbness in left side of face including lips cheek and forehead
28 2021-01-17 dizziness, pain At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, di... Read more
At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation. Medical history included birth control. Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin. The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site. On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
28 2021-01-17 feeling hot Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calmi... Read more
Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.
28 2021-01-17 weakness, dizziness difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchines... Read more
difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-01-19 pain Chills, nausea, body aches, joint pain, muscle aches, headache, swollen lymph nodes in neck
28 2021-01-19 migraine Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection s... Read more
Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)
28 2021-01-19 pain I have a fever of 102F, starting around 2pm, 24 hours after vaccine administration. I am at home, dr... Read more
I have a fever of 102F, starting around 2pm, 24 hours after vaccine administration. I am at home, drinking fluids and taking Tylenol. I just wanted to report it. Additionally, I have aches and chills, but I know that is expected.
28 2021-01-19 lightheadedness My daughter woke up at 2am and I started feeling like I would throw up and I sat down and blacked o... Read more
My daughter woke up at 2am and I started feeling like I would throw up and I sat down and blacked out and fell into our shower and hit my head and shoulder my husband had to shake me and wake me up and I also felt like I would have diarrhea- ER said it was a vasovagal event
28 2021-01-19 migraine R SIDED MIGRAINE, CHILLS, FEVER, MUSCLE ACHES, FATIGUE
28 2021-01-20 vertigo, dizziness Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 V... Read more
Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.
28 2021-01-21 speech disorder, pain 12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOS... Read more
12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS
28 2021-01-21 pain 6 hours - 36 hours after vaccine (starting day of) body aches and headaches 47 hours after vaccine... Read more
6 hours - 36 hours after vaccine (starting day of) body aches and headaches 47 hours after vaccine heart palpitations requiring an emergency department visit
28 2021-01-21 pain, migraine Body Aches, Chills, Sweats, Migraine, light sensitivity
28 2021-01-21 pain Headache, body ache and congestion
28 2021-01-21 tingling, numbness I just wanted to report an incident that occurred after receieving the first dose of the covid vacc... Read more
I just wanted to report an incident that occurred after receieving the first dose of the covid vaccine. It was not one of the possible reaction from covid vaccine but rather administrator error in injecting the vaccine. The symptoms appeared about 3 hours after receiving the vaccine, now have numbness, tingling, pain and burning sensation on my left pam in the arm of given vaccine. Obviously, the person giving the vaccine, hit the nerve.
28 2021-01-21 inability to speak, numbness One hour after vaccination patient experienced Left facial and tongue numbness that impacted her abi... Read more
One hour after vaccination patient experienced Left facial and tongue numbness that impacted her ability to speak clearly (similar to experience with numbing for a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. Dexamethasone 10mg given intramuscularly in ER.
28 2021-01-21 numbness, speech disorder Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (sim... Read more
Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (similar to numbness experienced with numbing prior to a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. She was given 10mg dexamethasone intramuscularly in the ER.
28 2021-01-24 dizziness, feeling hot 13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135... Read more
13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.
28 2021-01-24 pain, feeling hot, pain in extremity Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and... Read more
Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
28 2021-01-24 tingling Reporter received the first COVID-19 vaccine on 12/30/2020 and waited the recommended 15 minutes for... Read more
Reporter received the first COVID-19 vaccine on 12/30/2020 and waited the recommended 15 minutes for observation. After the observation period, she left the facility and started to notice tightness and what she describes as a "bubble" at the top of her throat. She also noticed a tingling sensation in the top of her lip, but did not notice any swelling. Reporter took 25 mg of liquid Benadryl and within an hour the sensation in her throat began to go away. Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken diphenhydramine following the reaction to her first dose. Around 08:40 AM, she began to feel tightening in her throat and some heaviness in her chest. She was evaluated by a nurse who took her blood pressure (normal), however, her heart rate was elevated (noted this could be that she was nervous following initial reaction and repeat tightness in throat). Around 08:55AM, she began to feel like her tongue was swelling and that she had a "bubble" on the top of her throat. She was taken to the Emergency Department for evaluation. She was given hydroxyzine, famotidine, and dexamethasone in the ED and was discharged and felt stable. She reported a continued odd sensation in her throat the evening of the second vaccination. This feeling resolved the next day, and she reports no additional side effects from the vaccine.
28 2021-01-24 tremor, seizure Severe shaking about 12 hours after injection. Started as shivering and turned into full body convul... Read more
Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.
28 2021-01-24 pain in extremity Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work ... Read more
Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work up with headache and nausea.
28 2021-01-24 pain in extremity WOKEN UP BY SEVERE ARM PAIN APPROXIMATELY 12 HOURS AFTER INJECTION. PAIN DID NOT CHANGE ENTIRE NEXT... Read more
WOKEN UP BY SEVERE ARM PAIN APPROXIMATELY 12 HOURS AFTER INJECTION. PAIN DID NOT CHANGE ENTIRE NEXT DAY. SLIGHTLY BETTER SECOND DAY AFTER, HOWEVER I WENT TO WRING OUT A WASHCLOTH IN THE AFTERNOON AND EXPERIENCED EXTREME HORRIBLE PAIN THAT RADIATED IN MY LEFT WRIST. I HAVE NEVER FELT A PAIN LIKE THAT, I WAS AFRAID SOMETHING WAS REALLY WRONG. IT SLOWLY SUBSIDED, AND SINCE THEN I HAVE BEEN CAREFUL WITH HOW I USE MY WRIST AND ARM, BUT IT IS STILL SOMEWHAT PAINFUL AND DOESN'T FEEL RIGHT. I AM AFRAID I WILL FEEL THAT PAIN AGAIN IF I MOVE/PUSH/LIFT ANYTHING IN A CERTAIN WAY.
28 2021-01-24 numbness, tingling [Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID... Read more
[Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID vaccine on 12/18/20 at 10:50. I began experiencing numbness and tingling from my knees to my toes 40 minutes following the vaccine in both legs. I am still experiencing tingling and numbness in my legs at times.
28 2021-01-24 pain, dizziness, weakness, pain in extremity weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more ... Read more
weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
28 2021-01-25 weakness, pain Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (pati... Read more
Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
28 2021-01-25 dizziness, pain in extremity Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in ... Read more
Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.
28 2021-01-25 tremor, dizziness, vertigo Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms... Read more
Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms started 5-10 minutes after patient received her 2nd Pfizer vaccine dose. Patient has h/o vertigo and reported vertigo, headache, nausea, and emesis following the first vaccine dose. Unsure if syncope 2/2 vaccine vs vaccine adminitration anxiety vs h/o vertigo. NS bolus, Benadryl, Ativan, Tylenol, and Motrin were given. Normal EKG. Symptoms improved and patient discharged from the ED.
28 2021-01-26 numbness ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way thr... Read more
ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.
28 2021-01-26 pain Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 3... Read more
Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
28 2021-01-26 slurring, dizziness, pain in extremity, inability to speak, weakness, tingling My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was ad... Read more
My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .
28 2021-01-26 bell's palsy Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's ... Read more
Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's palsy, She did go to the ER and report attached. She also reported a tennis ball size swollen lymph node in R underarm (armpit) on 1-14-21 for a day or two. very tender to touch.
28 2021-01-26 pain in extremity sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy tha... Read more
sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.
28 2021-01-27 pain in extremity Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigu... Read more
Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue
28 2021-01-28 pain Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a cont... Read more
Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.
28 2021-01-28 migraine Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous ... Read more
Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
28 2021-02-01 seizure, weakness Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous re... Read more
Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-04 pain in extremity After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue... Read more
After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later
28 2021-02-07 weakness, tingling Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her bo... Read more
Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.
28 2021-02-11 dizziness Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous repor... Read more
Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable other HCP reporting for herself. A 28-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medicatons were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced lightheadedness, weakness of muscles and rapid heart rate on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications. Information on the lot/batch number has been requested.
28 2021-02-14 slurring, speech disorder, dizziness, tingling Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pal... Read more
Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-16 pain, inability to speak stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day th... Read more
stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.
28 2021-02-21 pain in extremity, pain Chills, body aches, sore arm
28 2021-02-21 dizziness Mild-moderate dizziness for past 8 days
28 2021-02-22 pain Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection s... Read more
Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue
28 2021-02-22 pain Fever, chills, body ache, nausea, tiredness and fatigue for 36h, sore site of injection for 4 days
28 2021-02-22 pain Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours... Read more
Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours after shot. Took ibuprofen and acetaminophen for the duration of the symptoms Sunday night and all day Monday. By the time I woke up Tuesday morning (approx 42 hours after shot) the only remaining symptom was sore lymph nodes and more tired than usual.
28 2021-02-22 pain Headache fever body ache
28 2021-02-22 dizziness Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this m... Read more
Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this morning and thought she may have been hungry and needed to eat lunch and she thought it may be indigestion. Gatorade and water given to pt and pt tolerated well. BP checked 120/80, HR 95. PT advised that if symptoms persist go to urgent care or to the closest PCP. PT verbalized understand and stated she felt fine to leave.
28 2021-02-23 pain Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-yea... Read more
Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
28 2021-02-23 dizziness Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Fel... Read more
Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.
28 2021-02-23 pain in extremity Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-yea... Read more
Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EL3247), via intramuscular route of administration, on 26Jan2021 10:15 AM (at the age of 28 years old) as a single dose in the left arm for COVID-19 immunization at work clinic. Relevant medical history were anxiety, depression. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), aripiprazole (ABILIFY), iron, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 04:00 PM, the patient experienced sore arm/arm felt sore. No treatment was received for the event arm/arm felt sore. The outcome of the event arm/arm felt sore was recovering. Since the vaccination, the patient had not been tested for COVID-19.
28 2021-02-23 numbness, pain in extremity Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygi... Read more
Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygienist. Could feel left foot start to go numb and tingling and feel very cold. Took thin sock off foot, pinky toe was purple. Took pictures. Could not get foot to warm up with warm/hot compresses. Started having slight discomfort in lower back/butt with pain going down leg to toe within the hour. I believe this could be coincidence and have sciatic pain, but thought I should report just in case there are few other reported cases on this. Purple discoloration was gone when woke in morning on 2/23/2021 It is now 2/24/2021 and I am still having sciatic pain and numb pinky toe.
28 2021-02-25 tingling Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes le... Read more
Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.
28 2021-02-25 pain Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (... Read more
Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), intramuscular on the right arm, on 28Jan2021 07:30, at SINGLE DOSE for covid-19 immunisation, at the workplace clinic. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 28Jan2021 at 20:00, the patient experienced fever, chills, body aches and fatigue. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
28 2021-03-01 pain significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; hea... Read more
significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse. A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
28 2021-03-03 pain back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection s... Read more
back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.
28 2021-03-09 pain After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyze... Read more
After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyzed vocal cord. I went to the hospital since I am pregnant to check on my baby and myself. I have not fully recovered from my vocal cord. At the hospital a rapid Covid test was performed along with a flu swab and lab work.
28 2021-03-13 dizziness, unresponsive to stimuli, weakness Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unkn... Read more
Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).
28 2021-03-18 difficulty speaking tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bi... Read more
tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old female patient receive dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation. Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil) to an unknown date. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis. The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season. Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years. The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia on 08Jan2021 with outcome of unknown and "Vacematter 08:45". Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28. Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia. The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.
29 2020-12-31 tingling, pain, migraine Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches an... Read more
Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue
29 2020-12-31 pain in extremity Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wedn... Read more
Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.
29 2021-01-01 dizziness Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of light... Read more
Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of lightheadedness was quick .
29 2021-01-02 feeling hot, dizziness Throat tightness Hot Dizzy Nausea
29 2021-01-03 lethargy 12/21 - Fever (101.5), lethargy, headaches 12/22 - lethargy and headaches 12/23 - lethargy and head... Read more
12/21 - Fever (101.5), lethargy, headaches 12/22 - lethargy and headaches 12/23 - lethargy and headaches
29 2021-01-03 pain About 12 hours post vaccination, I developed body aches and fever and chills which persisted for ano... Read more
About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go. As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.
29 2021-01-03 dizziness Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate drop... Read more
Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate dropped. Husband was present and took me to the ED, where I regained consciousness gradually. Received treatment.
29 2021-01-03 pain Fever, body aches, chills, body aches and fatigue.
29 2021-01-03 migraine developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she de... Read more
developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-04 pain, tingling All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell... Read more
All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.
29 2021-01-04 numbness Left hand feels sleepy; This is a spontaneous report from a contactable health care professional nu... Read more
Left hand feels sleepy; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 14:00 as a single dose, for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included amoxicillin (AMOXICILLIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 16:45, the patient experienced left hand feels sleepy. No Treatment was given for the event. The clinical outcome of left hand feels sleepy was not recovered.
29 2021-01-04 dizziness Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after in... Read more
Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.
29 2021-01-04 numbness Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began ... Read more
Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.
29 2021-01-04 dizziness, tingling Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypne... Read more
Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.
29 2021-01-04 weakness, pain in extremity, feeling cold, dizziness Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness,... Read more
Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.
29 2021-01-04 pain Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessene... Read more
Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessened throughout the day (I did use analgesics), but still had chills, some achiness, and a headache the day after I received my vaccine.
29 2021-01-05 feeling hot, pain 1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain... Read more
1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea
29 2021-01-05 pain 30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persist... Read more
30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persisted for approximately 1 hour. Later in the evening around 1830, I developed chills and body aches. When I woke up the next day, all symptoms were gone.
29 2021-01-05 pain in extremity, pain Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned in... Read more
Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.
29 2021-01-05 tremor Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and ... Read more
Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.
29 2021-01-05 swollen extremities Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12... Read more
Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12 hours later after vaccine
29 2021-01-05 pain Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post va... Read more
Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post vaccine
29 2021-01-05 lightheadedness PRESYNCOPE BP 70 SYSOTLICALLY, IV INITIATED AND TAKEN TO EMERGENCY DEPT
29 2021-01-05 dizziness Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. H... Read more
Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.
29 2021-01-06 inability to speak 5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore ... Read more
5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat
29 2021-01-06 pain Fever of 101, chills, body aches
29 2021-01-06 pain in extremity Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely so... Read more
Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.
29 2021-01-06 feeling hot, pain Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site sorene... Read more
Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.
29 2021-01-06 migraine, balance disorder, dizziness, pain Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobi... Read more
Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
29 2021-01-06 migraine Migraine started about 24 hours after getting the 2nd shot on 1/4 at 9:20
29 2021-01-06 pain in extremity Next morning, I woke up with severe positional headache (headache with standing or sitting up, resol... Read more
Next morning, I woke up with severe positional headache (headache with standing or sitting up, resolved completely with ibuprofen and tylenol within 20 minutes). The next morning I also had a sore left deltoid, and soreness extending into my left chest and shoulder, which diminished throughout the day after ibuprofen and tylenol. I also had a left swollen armpit, which I interpreted as swollen lymph nodes. My left armpit was sore and was visibly swollen compared to the right. The left lymph node is still visibly swollen as I report this (approximatley 36 hours after vaccine administration), and is sore but less sore than initially. Of note, when I received the first vaccine in this series, my left deltoid was more sore than with the second administration, but soreness was limited to the deltoid and resolved within 3 days.
29 2021-01-06 pain On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This p... Read more
On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This progressed the following days, became itchy and painful. The pain was shooting. I saw my PCP office on 1/6 and was diagnosed with Shingles.
29 2021-01-06 dizziness Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feelin... Read more
Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine. Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.
29 2021-01-07 pain 2 hours after receiving vaccine started having severe pain in shoulder. Progressively got worse as ... Read more
2 hours after receiving vaccine started having severe pain in shoulder. Progressively got worse as the night went on. Jolting sharp pain with certain movements.
29 2021-01-07 speech disorder, difficulty speaking, tremor 29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and na... Read more
29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.
29 2021-01-07 pain Achy, tired, dull headache
29 2021-01-07 pain in extremity, pain Arm soreness, chills, achiness, lymphadenopathy
29 2021-01-07 pain Body aches; onset of fever /low grade fever; muscle aches; headache; chills about 11 hours after sho... Read more
Body aches; onset of fever /low grade fever; muscle aches; headache; chills about 11 hours after shot; patient received bnt162b2 first dose on 15Dec2020 16:00 and then second dose on 04Jan2021 14:15; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative. A 29-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular first dose on 15Dec2020 16:00 at single dose (batch/lot #: EH9899), and then second dose on 04Jan2021 14:15 at single dose (batch/lot #: EK9231) for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced onset of fever /low grade fever, muscle aches, headache, chills about 11 hours after shot on 05Jan2021 01:00 am with outcome of recovering, no treatment for above events, and patient also experienced body aches on unspecified date with outcome of unknown. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
29 2021-01-07 pain, weakness Fever, chills, weakness, body aches
29 2021-01-07 pain Onset Headache, Body Aches, Chills, Fatigue 10 hours after vaccine
29 2021-01-07 tingling Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards ... Read more
Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and "dead arm" feeling.
29 2021-01-07 dizziness, tremor Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, cl... Read more
Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness
29 2021-01-07 tenderness, dizziness, pain in extremity dizziness, body pain in arm chest and back, painful to touch.
29 2021-01-07 pain in extremity fever 99.6 for 12 hours, soreness in upper arm and injection site
29 2021-01-07 pain in extremity myalgias, fever, headache, left arm pain, chills
29 2021-01-07 dizziness red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadry... Read more
red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.
29 2021-01-07 tremor, pain in extremity strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extre... Read more
strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.
29 2021-01-08 pain, tingling Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only las... Read more
Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.
29 2021-01-08 dizziness Chills, dizzy, headache, injection site pain
29 2021-01-08 vertigo, dizziness Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccinat... Read more
Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccination. Went back to work, as Clinical Pharmacist. Found she felt dizzy, vertigo, and nauseated. Unable to concentrate or focus on her work. She went home to recover
29 2021-01-08 pain in extremity Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatig... Read more
Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatigue developed after administration of covid vaccine. Resolved by 1/1/21.
29 2021-01-08 pain Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to ... Read more
Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to alleviate symptoms, and went to sleep around 2pm, woke up for dinner and a shower and went back to sleep through the night
29 2021-01-09 pain After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 h... Read more
After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 hours starting 4 hours after shot. After first dose: injection site pain the next day
29 2021-01-09 tenderness Exquisitely tender right sided epitrochlear, axillary, and supraclavicular lymphadenopathy. Began ab... Read more
Exquisitely tender right sided epitrochlear, axillary, and supraclavicular lymphadenopathy. Began about 16 -20 hours after receiving vaccination. Still present at 36 post vaccination, but seems to be improving.
29 2021-01-09 dizziness Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccinatio... Read more
Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot
29 2021-01-09 dizziness Lightheadedness, mental status changes (foggy) with difficulty focusing
29 2021-01-09 pain, tingling Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body ac... Read more
Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.
29 2021-01-10 pain Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 9... Read more
Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 97.1 -> 99.4) lasted for about 12 hours
29 2021-01-10 pain Fever, Body ache and injection site soreness. Took paracetamol - felt better.
29 2021-01-10 lethargy Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph no... Read more
Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.
29 2021-01-10 pain Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get wo... Read more
Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get worse throughout the day. Unable to lift my arm very far without pain. Worse than any other injection recieved in the past. Pain throught the night-causing lack of sleep. Severe pain for about 24 hours or so then completely gone. My muscle in my arm then felt tight as if there was inflammation of some sort or an injury to the muscle. Upon lifting my arm it felt as if my arm was pulling back. No pain during this action but more of a weakness. No relief from anti inflammatory medicaiton or ice. Sensation in arm noted to be gone on 01/09/2021.
29 2021-01-10 pain Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. F... Read more
Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. Fatigue and exhaustion. Body aches. Headache.
29 2021-01-10 lightheadedness, dizziness Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, ... Read more
Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, Pulse 92-96, BP 115/68 and 104/66. SpO2 99-100% on room air Reaction: pale, lightheaded, said she felt like she ?was in a tunnel? after receiving vaccine, but felt better by the time she got to ED. Impression from provider: ?Acute Vasovagal response to injection?
29 2021-01-10 pain Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse th... Read more
Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.
29 2021-01-10 pain fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left ... Read more
fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left side of neck
29 2021-01-11 pain, pain in extremity, dizziness 1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my... Read more
1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever. I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate. 1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else. 1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.
29 2021-01-11 pain 12 hours following vaccination experienced fatigue, chills, body aches, and fever of 100.3 (t max) t... Read more
12 hours following vaccination experienced fatigue, chills, body aches, and fever of 100.3 (t max) that lasted 24 hours.
29 2021-01-11 pain Congestion, nausea, fatigue, body aches
29 2021-01-11 weakness Deep cough, muscle soreness throughout entire body, weakness, congestion and pressure in head
29 2021-01-11 pain During the first few hours following vaccination, I had soreness at the injection sight and a mild h... Read more
During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.
29 2021-01-11 pain Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of ... Read more
Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; This is a spontaneous report from contactable other healthcare professional (patient herself). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 03Jan2021, 10:00AM at a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, 07:00 AM, the patient experienced feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day (no time reported), her entire body ached like that caused by the flu. No treatment was received for the events. Outcome of the events at the time of last observation in Jan2021 was reported as recovered. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information on the batch/lot number has been requested.
29 2021-01-11 pain Headache, nausea, body aches, stuffy nose. Resolved.
29 2021-01-11 pain Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10... Read more
Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after
29 2021-01-11 pain I started experiencing chills around 9:00 pm the same day I received the vaccine. I then began havin... Read more
I started experiencing chills around 9:00 pm the same day I received the vaccine. I then began having body aches, headache, and joint pain. I did not seek professional treatment but took Tylenol. It is now one day after receiving the vaccine and my symptoms are better but not yet completely resolved.
29 2021-01-11 pain Nausea Body aches Fatigue Headache Injection site soreness
29 2021-01-11 dizziness, feeling hot Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began ... Read more
Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.
29 2021-01-11 dizziness, pain, pain in extremity Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day.... Read more
Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.
29 2021-01-11 pain This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b... Read more
This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular from 17Dec2020 07:00 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 17Dec2020 18:00, it was reported that the patient experienced fever, chills, aches, HA, stomach pains for first two nights, and only at night. Woke up, fine by morning. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the lot/batch number has been requested.
29 2021-01-11 pain in extremity, feeling hot, tremor body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle... Read more
body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.
29 2021-01-11 pain in extremity she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was ... Read more
she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.
29 2021-01-12 pain, pain in extremity Arm pain and neck pain, body aches, fever, headache
29 2021-01-12 pain Body aches, joint pain, headache, low-grade fever. Symptoms lasted approximately 30 hours.
29 2021-01-12 pain, pain in extremity Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme f... Read more
Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme fatigue and arm soreness. Stated she was not able to tie her hair or use arm without pain. Denies fever, body aches at this time.
29 2021-01-12 pain in extremity Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on... Read more
Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on 18Dec2020; This is a spontaneous report from an other hcp. A 29-year-old female non-pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration at left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies. No other medical history. Concomitant medication included ibuprofen, alprazolam, ergocalciferol (VIT D), clarithromycin (CLARITIN), cranberry. No other vaccine in four weeks. The patient received first dose (lot number= EK5730) via an unspecified route of administration at Left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient experienced Fever 101.0F, chills, headache, fatigue, arm soreness on 05Jan2021 20:00. The patient underwent lab tests and procedures which included body temperature: 101.0 fahrenheit on 05Jan2021. No covid prior vaccination, Covid was test post vaccination via Nasal Swab on 22Dec2020 with result of negative. The events Fever 101.0F, chills, headache, fatigue, arm soreness were recovering. Treatment of acetaminophen received for the events Fever 101.0F, chills, headache, fatigue, arm soreness.
29 2021-01-12 pain Fever of 101.5 Chills/body aches Muscle stiffness General malaise Nausea Headache
29 2021-01-12 pain Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body ac... Read more
Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body aches, diarrhea and abdominal cramps
29 2021-01-12 dizziness, pain On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness ... Read more
On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness with intermittent slight rash. On 1/7/2021 she developed severe muscle pain, joint pain, fever, and intermittent lightheadedness and dizziness. She went to the emergency room on 1/10/2021 but no changes made in medications. She reports her BP was 207/111 and her pulse was 165/minute and still runs that high now. She had hypertension and tachycardia. About 1.5 years ago she had a history of hypertension and tachycardia. 1/12/2021 this person continued to have hypertension and tachycardia. Instructed to make an appointment to see her primary physician.
29 2021-01-12 dizziness Patient felt dizzy, and had a headache and required prolonged rest post second COVID vaccine
29 2021-01-12 pain, pain in extremity Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. ... Read more
Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day. I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally. On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day. I noted clavicular lymph nodes as well. About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg. These symptoms were responsive to acetaminophen. The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9. Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination. This axillary node persisted until Monday, 1/11.
29 2021-01-12 pain The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9... Read more
The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9:30 pm-7:30 am body aches/muscle aches/joint pain so severe unable to sleep without waking up every hour 7:30 am took Ibuprofen and slept until 3 pm, exhaustion, headache 1/11/21 fever of 100.1 and body aches, headache and exhaustion, took Ibuprofen 1/12/21 back to normal functioning no aches/pains/fever
29 2021-01-12 dizziness, pain This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated ... Read more
This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated she had a fever of 102. Her body ached all over from head to toe. She had dizziness with an intermittant rash. She did go to the emergency room on Sunday 1/10/2021 with hypertension and tachycardia. Her BP was running at around 207/111 and her pulse has stayed around 165 even through today on 1/12/2021. She did state about 1.5 years ago she experienced tachycardia and hypertension but not since. She did not get any new medications upon her visit to the emergency room. She was going to try to see her physician today if possible on 1/12/2021.
29 2021-01-12 weakness Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn,... Read more
Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness
29 2021-01-12 pain fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, reso... Read more
fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, resolved roughly 24hrs after onset
29 2021-01-12 pain fever; body aches; This is a spontaneous report from a Pfizer sponsored program. A contactable consu... Read more
fever; body aches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via unspecified route of administration, on 15Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included stress, cold sores, and birth control. Concomitant medications included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, fluticasone propionate (FLONASE), and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient received the vaccine through work. The first time she got it, she had a fever on 16Dec2020 that lasted in 24 hours (until 17Dec2020). She also had body aches that lasted for 48 hours. Those were from the 16th to 18Dec2020. She received the first dose on the 15Dec2020. Then, the morning of the 16Dec2020, she noticed body aches. She didn't get a fever until later that afternoon. She got the vaccine because she works in a nursing home. She is an essential worker who is at high risk. The patient recovered from the fever on 17Dec2020 and recovered from body aches on 18Dec2020.
29 2021-01-13 pain 1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall ski... Read more
1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall skin sensitivity 48 hours: respiratory symptoms- cough, sore throat, runny nose, congestion
29 2021-01-13 tingling, weakness, dizziness, pain in extremity 1 week history of significantly worsened (previously present "low back strain" lower back pain that ... Read more
1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.
29 2021-01-13 feeling hot, dizziness 1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken... Read more
1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,
29 2021-01-13 pain in extremity Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at... Read more
Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at this time.
29 2021-01-13 pain Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild... Read more
Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild headache and back pain. EE reports she took 400 mg motrin at 0700 and came to work. EE reports around 09:00 worsening HA and nausea. EE took her temp (99.1) and took 1000 mg Tylenol. EE advised by manager to call vaccine support line for recommendations. Last day of work and shift - ? EE currently at work Home remedies? ? see ?symptoms? for narrative Any improvement? - mild Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE denies covid-19 exposure without proper PPE and denies travel. EE does not meet criteria to be COVID tested at this time. EE educated to continue to manage per TCH Illness in the Workplace Policy and to notify manager if she needs to leave work today. EE verbalized back understanding and denied further questions at this time.
29 2021-01-13 pain Fever (T-max 100.4); headache; body aches; This is a spontaneous report from a contactable health ca... Read more
Fever (T-max 100.4); headache; body aches; This is a spontaneous report from a contactable health care professional, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284) in the left arm on 07Jan2021 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Hospital. Medical history included Stiff-man syndrome, polycystic ovarian syndrome and known allergies to soy, sesame, and walnuts. Concomitant medication included tramadol (TRAMADOL), gabapentin (GABAPENTIN), methocarbamol (ROBAXIN), dienogest, estradiol valerate (NATAZIA), insulin (INSULIN). The patient previously experienced drug hypersensitivity to Penicillin, Neosporin, and Levaquin. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), in the left arm on 17Dec2020 11:AM. No other vaccines were given within 4 weeks except the first dose of BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Jan2021 17:30, the patient experienced fever (t-max 100.4), headache and body aches. Lab data include body temperature: t-max 100.4 on 07Jan2021. No treatment was given for the events. The clinical outcome of the events fever (t-max 100.4), headache and body aches was recovering.
29 2021-01-13 weakness, pain I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I star... Read more
I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.
29 2021-01-13 pain, pain in extremity Lymph node swelling to right axillary with pain that radiates to the right breast, down the right ar... Read more
Lymph node swelling to right axillary with pain that radiates to the right breast, down the right arm, and around the back to the right shoulder blade. Pain limited daily activity to the right arm. Pain decreased for about 12 hours and then the pain returned again around 06:00, Thursday 1/14/2021 with lymph node larger than previous day. Area is tender and painful with every day movements. Will consult with primary health care provider if pain/swelling does not improve or gets worse.
29 2021-01-13 pain, numbness, tingling Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, ... Read more
Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.
29 2021-01-13 dizziness Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but ... Read more
Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but did not loose consciousness. She stated that she may have not eaten enough for lunch and has a fast metabolism that may have contributed to her symptoms. Patient transported from hospital vaccine center to hospital ED for further evaluation.
29 2021-01-13 pain, weakness Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, s... Read more
Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.
29 2021-01-13 balance disorder Wave of what felt like was an adrenaline rush and then chest tightness. When getting up to stand fel... Read more
Wave of what felt like was an adrenaline rush and then chest tightness. When getting up to stand felt as if I was going to fall down. Nurse there took HR & BP. HR was about 110. BP was normal range. Self resolved within 15 min.
29 2021-01-13 pain chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physi... Read more
chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).
29 2021-01-13 pain cold sore; body aches; They have worsened as the day went on; stress; This is a spontaneous report f... Read more
cold sore; body aches; They have worsened as the day went on; stress; This is a spontaneous report from a contactable other healthcare professional (patient, Physical Therapist) from a Pfizer-sponsored program. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. Medical history included cold sores. Concomitant medication included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, ongoing fluticasone propionate (FLONASE ALLERGY RELIEF), ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on 15Dec2020 for COVID-19 immunization and experienced fever and body aches. The reporter wanted to verify if it was an interaction. She didn't feel like it was a drug interaction. She was questioning if there could be a drug interaction. She took Valtrex for cold sores on her face. She received her second dose of the COVID vaccine yesterday on 06Jan2021. Today 07Jan2021, she got a cold sore this morning and took Valtrex. She was wondering if the Valtrex, being an antiviral, could affect the vaccine in any way. She got the cold sores randomly anyway. They come on because of stress. She has a history with them. Caller didn't have a prescribing doctor. She got the vaccine through work. This time for second dose she developed body aches only. She received the vaccine yesterday 06Jan2021, and developed body aches today 07Jan2021. They have worsened as the day went on, but she was at work. Since she was home now and not moving around as much they weren't as bad. She got the vaccine because she worked in a nursing home. She was an essential worker who was at high risk. The outcome of events was unknown.
29 2021-01-13 lethargy, migraine nausea migraine unable to move left arm lethargy
29 2021-01-14 tremor, pain Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on ... Read more
Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.
29 2021-01-14 pain Low grade fever, pelvic pain, body ache, fatigue. Resolved.
29 2021-01-14 pain in extremity Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Signifi... Read more
Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Start Date/Time: 08Jan2021 12:45 PM/ Start Date/Time: 21Dec2020 10:15 AM; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date not reported), intramuscular in the right arm on 08Jan2021 12:45 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the right arm on 21Dec2020 10:15 at single dose for COVID-19 immunisation. The patient experienced significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
29 2021-01-14 pain body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from ... Read more
body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.
29 2021-01-14 pain on 1/12 symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea... Read more
on 1/12 symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea , vomitingx4 and fatigue
29 2021-01-14 pain, pain in extremity whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain wi... Read more
whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
29 2021-01-15 pain, pain in extremity, feeling hot Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours ... Read more
Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours after administration), woke up with chills, body aches, headache, hands and feet hot, skin hot to touch/tactile fever.
29 2021-01-16 pain in extremity, pain Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, ... Read more
Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.
29 2021-01-17 pain Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness a... Read more
Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.
29 2021-01-19 pain in extremity 01/19/2021 Fever- 102.0 F Headache Chills Sore arm 01/20/2021 Fever 100.1, sore arms, chills
29 2021-01-19 dizziness 10 minutes after receiving the vaccine patient complained of feeling sweaty and dizzy. She had mild... Read more
10 minutes after receiving the vaccine patient complained of feeling sweaty and dizzy. She had mild tachycardia. She had no nausea, vomiting or diarrhea. She had no shortness of breath, or wheezing.
29 2021-01-19 dizziness About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to deve... Read more
About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to develop a headache. By the next day my headache became overwhelming and the the dizziness became so pronounced that I could not stand for more than 5 minutes at a time. I a had an intolerable headache on the entire bottom of my head that made my neck start to hurt. I felt nausea that did not improve until four days later. My joints were hurting sharply two days after the immunization and lasted two days. Most of my symptoms improved on the 13th of January, but were still lingering. About 5 days after the shot my symptoms resolved completely.
29 2021-01-19 pain, dizziness Fatigue, headache, dizziness, body aches on same day Two days later chest pains, joint pains
29 2021-01-19 feeling cold, tremor, tingling, dizziness I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking... Read more
I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.
29 2021-01-19 pain Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fev... Read more
Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fever 20 hours after. Relieved with Tylenol and Motrin, ice packs.
29 2021-01-19 pain headache body aches joint pain
29 2021-01-21 pain 12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, lo... Read more
12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, low grade fever 99F.
29 2021-01-21 pain Fever, body chills, body aches, nausea, fatigue, headache, 14 hours
29 2021-01-21 feeling hot, tremor, pain, pain in extremity First Dose- I had a headache after the shot and tremors started that even and throughout the night.... Read more
First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.
29 2021-01-21 pain in extremity Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wie... Read more
Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wierd, light headache
29 2021-01-21 dizziness Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused... Read more
Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused further care and her symptoms improved then left the waiting area at 2:55pm. Before leaving, her vitals were BP 133/69, HR 70 and SpO2 100% on room air.
29 2021-01-21 dizziness I woke up the morning after the vaccine and felt very nauseous with occasional lightheadedness. I wa... Read more
I woke up the morning after the vaccine and felt very nauseous with occasional lightheadedness. I was also extremely fatigued and found it difficult to get out of bed or off of the couch. I had a severe headache that lasted the majority of the day. Thursday's are typically my day off therefore I did not have to call out of work sick, however I most likely would have if I had been scheduled that day.
29 2021-01-21 dizziness LIGHTHEAEDED, FEELING WOOZY HEART RATE 140 -160 BP UP TO 150/80 EXPERIENCED SIMILAR WITH FIRST D... Read more
LIGHTHEAEDED, FEELING WOOZY HEART RATE 140 -160 BP UP TO 150/80 EXPERIENCED SIMILAR WITH FIRST DOSE OF VACCINE.
29 2021-01-21 pain body aches for 36 hours and low grade fever for unknown amount of time
29 2021-01-21 pain chills, severe body aches, upset stomach, fatigue
29 2021-01-24 migraine About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started ... Read more
About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started about 4pm, lasted through going to sleep at 9pm, and then woke up fine.
29 2021-01-24 pain Body aches and joint pain increased over the day. Had a fever and no appetite. Shortness of breath.
29 2021-01-24 dizziness, pain Body aches, fatigue, dizziness, brain fog.
29 2021-01-24 pain, pain in extremity Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan20... Read more
Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.
29 2021-01-24 pain, bell's palsy, nerve pain Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/... Read more
Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
29 2021-01-24 pain in extremity I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while wait... Read more
I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while waiting the allotted 30 minutes. The next morning, January 25th 2021, I started to experience arm soreness and blurry vision. The blurry vision is worse in my left eye. My vision has not improved after waking up, taking a shower and putting saline drops in both eyes. The best way to describe the sensation is hazy, blurry and sometimes double vision.
29 2021-01-24 pain PATIENT REPORTS CHILLS, FEVER, BODY ACHES, SHORTNESS OF BREATH BEGINNING 12 HOURS POST VACCINE #2
29 2021-01-24 tingling Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. ... Read more
Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. 3 weeks post injection.
29 2021-01-24 feeling cold, pain in extremity, migraine Severe injection site pain that began around 2 hours and went into the evening, severe in the evenin... Read more
Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.
29 2021-01-24 pain severe headache, Muscle/body aches, severe Fatigue
29 2021-01-25 pain, weakness Body aches, fatigue, HA, weakness, increased BP
29 2021-01-25 pain in extremity, pain Body aches, headache, nausea, vomiting, chills, fatigue, arm tenderness
29 2021-01-25 dizziness Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneo... Read more
Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneous report from a contactable other health care professional. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), intramuscular on 24Dec2020 08:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included allergic to nuts and peaches. There were no concomitant medications. On 24Dec2020 08:15, the patient experienced Dizziness within 15 minutes of receiving vaccine; couple of hours after patient reported headache and high blood pressure x2 days. After 2 days both headache and high blood pressure subsided. The patient received treatment for the event headache (Tylenol). It was reported that the patient had a physician office visit. The outcome of the event dizziness was recovered on an unspecified date, while the events headache and hypertension was recovered on 26Dec2020.
29 2021-01-25 pain Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable oth... Read more
Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), intramuscular in the left arm on 11Jan2021 12:30 at a single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), intramuscular in the left arm on 12Dec2020 11:30 at the age of 28 years old for COVID-19 immunization. The patient had not been tested for COVID-19 since the vaccination. On 11Jan2021 20:00, the patient experienced fatigue, body aches, sensitive skin, and chills. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
29 2021-01-25 pain Fever; nausea; vomiting; chills; body aches; This is a spontaneous report from a contactable nurse (... Read more
Fever; nausea; vomiting; chills; body aches; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on the left arm on 11Jan2021 08:00 both via an unspecified route of administration at a single dose for Covid-19 immunization. The patient medical history was reported as none. The patient takes multivitamins. On 11Jan2021 19:00, the patient experienced fever, nausea, vomiting, chills and body aches. The patient did not received any treatment for all the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
29 2021-01-25 dizziness, pain HA, dizziness, minor chest pain, body chills, fever starting 1/24/21 Notably, pt had an IV iron infu... Read more
HA, dizziness, minor chest pain, body chills, fever starting 1/24/21 Notably, pt had an IV iron infusion on 1/22/21
29 2021-01-25 dizziness swelling on the face; dizzy; This is a spontaneous report from a contactable consumer (patient). A 2... Read more
swelling on the face; dizzy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm (upper shoulder) on 11Jan2021 at a single dose for COVID-19 immunisation. The patient has no other medical history and no concomitant medications. The patient stated that she got the first shot for the covid vaccine yesterday in the evening and now she is feeling swelling on the face. When she got up in the morning, she felt swelling on the face. She is asking on what she has to do. She also felt a little dizzy. She was dizzy when she got up in the morning, she did not feel anything yesterday, she felt everything today. The outcome of the events was not recovered. She has had no positive test for covid before the vaccine. She had a negative test a few days ago this month in Jan2021. She got the test on a Monday and got the results on Friday.
29 2021-01-26 weakness, feeling hot, numbness, migraine, dizziness 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressu... Read more
1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
29 2021-01-26 pain Approximately 10 hours after receiving 2nd dose of vaccine, onset of moderate joint pain, headache, ... Read more
Approximately 10 hours after receiving 2nd dose of vaccine, onset of moderate joint pain, headache, body aches and chills noted. Symptoms persisted for 16 hours without intervention of medication. After 16 hours, symptoms were alleviated with 2 doses of 1000mg acetaminophen taken 6 hours apart. 1st dose at 11am on 1/26/21 and second dose at 5pm on 1/26/21
29 2021-01-27 pain in extremity Swollen lymph node to right axillary; Swollen lymph node to right axillary. Pain radiates to right b... Read more
Swollen lymph node to right axillary; Swollen lymph node to right axillary. Pain radiates to right breast, down right arm and around to the back and right scapula area/ tender to touch; Pain radiates to right breast; Pain radiates to right breast, down right arm; Pain radiates to right breast, down right arm and around to the back; Pain radiates to right breast, down right arm and around to the back and right scapula area; Pain caused inability to do daily activities; This is a spontaneous report from a contactable nurse (patient). A 29-years-old female patient ( received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 12Jan2021 07:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient had allergies to sulfamethoxazole, trimethoprim (BACTRIM), amoxicillin. The historical vaccine included the first dose of BNT162B2 at right arm on 21Dec2020 07:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node to right axillary, pain radiates to right breast, down right arm and around to the back and right scapula area, pain caused inability to do daily activities and area was tender to touch from 13Jan2021 02:00. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the batch number has been requested.
29 2021-01-28 nerve pain 1week after second shot started experiencing facial nerve pain. No medical history of any pain befor... Read more
1week after second shot started experiencing facial nerve pain. No medical history of any pain before. Negative etiology from dentist. Received 5 day course of prednisone 50mg daily which resolved pain, however 1 day after finishing course pain returned. Worse at night with bouts of pain every 30 minutes when trying to sleep. Received steroids and carbamazepine from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode.
29 2021-01-28 numbness Chest tightness worse with expiration, numbness in hands
29 2021-01-28 migraine, tremor Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature w... Read more
Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.
29 2021-01-28 pain Pregnant. Due august 2, 2021 Having fever (up to 100 F), headache, nausea, vomiting, aches
29 2021-01-28 seizure, tremor Syncope versus seizure with urinary incontinence and shaking. Transported to ED via EMS.
29 2021-01-28 feeling cold The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it... Read more
The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire. I had a rash on the opposite arm that i had the injection. I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat. This morning i woke up and the rash looks worse.
29 2021-01-28 difficulty speaking raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneou... Read more
raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
29 2021-01-28 pain the redness around the site came back; the redness around the site came back; headache; body aches; ... Read more
the redness around the site came back; the redness around the site came back; headache; body aches; chills; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3246 and Expiration Date unknown) via intramuscularly on 12Jan2021 08:15 AM (Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via intramuscularly on 21Dec2020 05:15 PM (Right arm) at single dose for COVID-19 immunisation. With first dose, patient had redness to the site the day after injection. It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine, the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large (have pictures for comparison throughout the days). Treatment included oral antibiotic and it slowly began to fade and go away. Other medical history was reported as Attention deficit hyperactivity disorder (ADD), eczema, psoriasis. The concomitant medications included unspecified Birth control, vitamin b complex (VITAMIN B) and ergocalciferol (VIT D). No other vaccine in four weeks. After second vaccine patient had a typical immune response- headache, body aches, chills, etc on the first day after vaccination and then on the second day post vaccination the redness around the site came back. Patient worried it was going to continue to grow again. The outcome of events was unknown.
29 2021-01-29 dizziness, weakness "Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan.... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm
29 2021-02-01 dizziness Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibupr... Read more
Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.
29 2021-02-03 numbness Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hour... Read more
Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.
29 2021-02-10 pain in extremity, tingling anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feelin... Read more
anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
29 2021-02-21 facial paralysis Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began ... Read more
Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began on 2/18 with numbness, woke 2/19 with no control of facial muscles Received steroids and antivirals, no improvements
29 2021-02-21 tenderness Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically... Read more
Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically occurs to me right before getting a fever or becoming sick)
29 2021-02-21 dizziness, tenderness, tremor, weakness High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache a... Read more
High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.
29 2021-02-21 feeling cold, pain, pain in extremity Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes,... Read more
Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.
29 2021-02-21 tingling, numbness, weakness Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder... Read more
Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.
29 2021-02-21 weakness The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of c... Read more
The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of consciousness for undetermined time period, facial trauma resulting in fractures of maxilla and teeth
29 2021-02-21 numbness numbness and tingling in R arm and neck. Then next day when I followed up with patient the numbness... Read more
numbness and tingling in R arm and neck. Then next day when I followed up with patient the numbness and tingling had resolved and she stated her neck and R shoulder blade area were sore.
29 2021-02-22 dizziness, weakness, feeling hot Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of t... Read more
Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of tongue numb and she had pressure on the left side of her head, her BP dropped and she felt weak. No medications given. She felt better after 10 minutes. She called her doctor and he gave her an epi pen and told her not to take the 2nd dose of Pfizer. She says she felt dizzy and weak for 3 weeks afterwards, but fine now.
29 2021-02-22 pain in extremity Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to wa... Read more
Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.
29 2021-02-22 numbness Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. Aft... Read more
Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.
29 2021-02-22 dizziness Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER... Read more
Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER with labs done (tryp 4.8). Discharged.
29 2021-02-22 weakness Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives... Read more
Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared. Monday redness on face and by Tuesday all hives had resolved. Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
29 2021-02-23 migraine Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Ir... Read more
Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
29 2021-02-24 numbness, pain in extremity Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's a... Read more
Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection (which is very rare on me), and was treated with antibiotics. With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
29 2021-02-25 pain Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurs... Read more
Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurse reporting for herself. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old via intramuscular in the left arm on 28Jan2021 01:00 PM at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced rigors, pain at injection site, body aches on 29Jan2021 at 03:00 AM. No treatment was received for the events. The nurse considered the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
29 2021-03-02 dizziness Dizziness; tiredness; This is a spontaneous report from a contactable consumer (patient). A 29-year-... Read more
Dizziness; tiredness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (vaccine location=left arm) on 29Jan2021 12:45 at a single dose for COVID-19 immunization at a hospital. Medical history was not reported. Concomitant medications included prenatal vitamins. No other vaccine in four weeks. No covid prior vaccination. On 29Jan2021 06:30 PM (as reported), the patient experienced dizziness and tiredness, onset less than one hour post injection. Symptoms worsened into following day. No treatment received for the events. No covid test post vaccination. The outcome of the events was not recovered. Information on batch/lot number was requested.
29 2021-03-02 pain fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first ... Read more
fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El9362; expiration date: unknown) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 29Jan2021 16:45 at a single dose for covid-19 immunization. Medical history included hypothyroidism, PCOS (polycystic ovarian syndrome) and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, metformin and vitamin nos (MULTIVITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: Ek4176) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 12Jan2021 16:45 at a single dose for covid-19 immunization but had lump on neck, sore arm, diarrhea starting day 3 through today and sore rib. The patient received the most recent COVID-19 vaccine in a hospital. It was reported that the patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021. On an unspecified date after the second dose, the patient had fever, chills, aches, headache, fatigue, loss of appetite and dulled taste. It was unknown if the patient received treatment for the adverse events and events were considered as non-serious. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.
29 2021-03-02 pain in extremity sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer... Read more
sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
29 2021-03-05 dizziness 49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doct... Read more
49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doctor who sent me to a hearing test. My right ear got damaged and cannot hear below ~40-50 decibel on all frequencies. + I got tinnitus. The treatment I got is Prednisolone 60 mg daily for a week. 4 days, nothing changed so far
29 2021-03-18 pain, tingling, numbness on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; ... Read more
on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
29 2021-04-11 feeling hot syncope and collapse (most likely vasovagal); hypoglycemia; got hot; This is a spontaneous report fr... Read more
syncope and collapse (most likely vasovagal); hypoglycemia; got hot; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 27Mar2021 10:15 (at the age of 29 years) as single dose for covid-19 immunization. The vaccination facility was Pharmacy/drug store. The patient has no medical history and no known allergies. The patient was not pregnant. No vaccines were given 4 weeks prior. No prior issues with vaccines, no health issues, had cereal and juice two hours before vaccine and was not hungry. The patient has no COVID-19 prior to vaccination. The patient was not tested post vaccination. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC). Historical vaccine includes dose 1 of bnt162b2, on 25Feb2021 (05:15 PM) at the left arm for COVID-19 immunization at the age of 29 years. On 27Mar2021 at 1030 AM, 10 minutes (as reported) after receiving vaccine and during wait period, got hot and passed out. Ambulance was called and transported to hospital. CMP, serum pregnancy test, troponin (ekg), urinalysis with reflex culture, CBC/auto differential, Glucose WH-BLD lab tests performed on 27Mar2021. Monitored pulse and oxygen on 27Mar2021. Diagnosis-syncope and collapse (most likely vasovagal) and hypoglycemia (unspecified). The events resulted in Emergency room/department or urgent care visit and did not receive treatment. The outcome of the events was unknown. Information on about lot/batch number has been requested.
30 2020-12-31 facial paralysis, tingling, numbness 12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermitten... Read more
12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, "pings " of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists
30 2020-12-31 lightheadedness Chills, myalgias and pre-syncope
30 2020-12-31 pain The next day I had a sore throat, and now it has developed into a cold. Sore throat, running nose, h... Read more
The next day I had a sore throat, and now it has developed into a cold. Sore throat, running nose, had some chills and body aches.
30 2021-01-01 pain 100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, sl... Read more
100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, slight headache, swollen lymphnodes
30 2021-01-01 tingling, numbness Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain... Read more
Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.
30 2021-01-01 dizziness, pain Very severe body aches and feeling lightheaded, causing fall on the ice
30 2021-01-02 pain in extremity, pain Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throug... Read more
Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throughout entire body, had very bad chills, and was unable to sleep. By 9 am I was finally able to sleep one hour and awoke sweating, but chills had subsided. Body aches did not subside until Wednesday morning (vaccine was administered Monday).
30 2021-01-03 swollen extremities, tenderness For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after... Read more
For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after my vaccination, my left armpit started feeling sore. This has continued to today where I have left armpit swelling and what feels to be a swollen, hardened lymph node in my armpit. It feels like a hardened lump that is not fixed and is tender when I palpate it. On visual inspection, I can tell that my left armpit is more swollen than my right armpit (which is normal). It hurts to have my arm at my side and it hurts to lay on my left side at night when I am sleeping.
30 2021-01-03 pain in extremity I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion... Read more
I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion sneezing sniffling and low grade fever 99.6. on the 23rd loose stools nasal drainage, I called the hospital hotline and I had to be off for ten days and went to Urgent care and took a rapid test and the test was positive. I have been quarantined for 14 days . The 25th was probably the worst day the 26th was a little better. the 27th symptoms were more mild and I also had diarrhea The 28th I woke up with a headache and light sniffles and the 27th I had no symptoms
30 2021-01-03 tremor Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red ... Read more
Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.
30 2021-01-03 dizziness, vertigo Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine u... Read more
Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine until about 6 hours later. At that point, I started to get very dizzy and lightheaded. Every time I opened my eyes, everything was spinning. This lasted four about 3-4 hours. I kept breaking out into sweats. I had a horrible headache for about 4 days straight. I am still continuing to having headaches. I am still having hot flashes and dizziness episodes at times that go away after about a few minutes. Two days ago, I stated to developing swelling in my hands with achy joints which has not gone away.
30 2021-01-04 pain, pain in extremity 12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For t... Read more
12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For the next 11 hours i had chills, severe body aches, a headache and spiked a fever to 101. The following day after ~12 hrs of symptoms I began to improve slightly and all that remained was a severe headache and body aches. Now, I am about 32 hours in to the adverse event and I still have a headache and sore arm/shoulders but other symptoms have resolved.
30 2021-01-04 lightheadedness, dizziness 12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FE... Read more
12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FELT LIGHT HEADED AND DIZZY. NEAR SYNCOPY EPISODE, TUNNEL VISION, PALE.
30 2021-01-04 pain in extremity, pain Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; Th... Read more
Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19. Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication. Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.
30 2021-01-04 dizziness, pain It looks like one of the ingredients may have an animal cell lipid; Syncope; Dizziness; feeling fain... Read more
It looks like one of the ingredients may have an animal cell lipid; Syncope; Dizziness; feeling faint; like going to pass out now and then; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; This is a spontaneous report from a contactable nurse reporting for herself. This A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9899), intramuscular at single dose in the left arm on 22Dec2020 09:00 for covid-19 immunisation. Medical history included reaction to pork, porsine and/or if she ever was exposed to exposed to heparin. There were no concomitant medications. On 23Dec2020, the patient experienced syncope (medically significant), dizziness (medically significant), feeling faint; like going to pass out now and then (medically significant), overall achiness, severe headaches, fever. The outcome of the events syncope, dizziness, feeling faint; like going to pass out now was recovering and outcome of overall achiness, severe headaches, fever was recovered on 24Dec2020. The patient ask: are there any animal products, pork gelatin or a lipid form of that contain in the vaccine? The events were described as follows: She experienced a significant amount of syncope and dizziness, for greater than 4 or 5 days post-receiving the vaccination. Also feeling faint like she is going to pass out every now and then. Has a more important question, wondering along with the doctors if one of the ingredients may have an animal product, like pork gelatin or a lipid form of that. It looks like one of the ingredients may have an animal cell lipid and was wondering if she was having a reaction to that. Declines to provide primary care provider details. States she received this first dose at occupational health in her workplace. Received the vaccine on the 22Dec2020 at 9am. 24 hours post vaccination, 1 day after, the syncope, dizziness, feeling faint started. Also the other symptoms, overall achiness, severe headaches, and fever were also experienced, but they stopped after that 24 hours. Those were expected since it was listed as side effects that popped up, so she expected those and they stopped after 24 hours. The syncope, dizziness, and faint feeling are not any worse and are very slowly improving, but she still has it and had to call out of work today because of it. That's consistent. Mentions it takes her a while to get down the stairs when getting product details for the COVID-19 vaccine. Unable to provide the vaccine NDC or expiry, or dose. Did not have any other vaccines at time of this one and none 4 weeks prior. Had to call a (company withheld) doctor and has to go to occupational health tomorrow to be seen. Declines having COVID virus. No further details provided.; Sender's Comments: Based on the compatible time association, the events syncope and dizziness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-01-04 dizziness Light headed
30 2021-01-04 pain in extremity, dizziness Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed ch... Read more
Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed chills and fatigue. At 6am on 12/18/2020, patient developed fever (temperature 100.2) and a very sore arm. Patient took acetaminophen (Tylenol) at 6:30am for the fever and pain. By 1pm on 12/18/2020, patient reports headache and dizziness. Patient took Rizatriptan (Maxalt) for the headache and dizzy, but it did not help. Patient took ibuprofen at approximately 4pm. Patient felt normal at 5:30pm on 12/18/2020. Took Tylenol at 6:30 for the sore arm. Took Maxalt for the headache/dizziness (sometimes migraines make me dizzy, maxalt didn?t help). Took ibuprofen around 3-4ish? And felt fine by 5:30.
30 2021-01-04 pain Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a sponta... Read more
Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 11:00 single dose for preventive. Medical history included depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for depression. The patient previously took flu vaccine for immunization. The patient received the Covid 19 vaccine on Wednesday. Patient stated there was a possibility of feeling achy just a general possibility of not feeling well like feeling tired, like it was she had that flu, vaccine too. But, her symptoms had persisted and she also had an isolated sore throat that started after she got her vaccine. She understood that the vaccine did not cause Covid but she was not sure like if having a sore throat was what other people have reported or this was something where she should go and get tested. Physician stated that question hadn't been answered by the previous department. When probed if the indication was a preventive measure for Covid, Physician stated "Preventive." Event (sore throat) started on 23Dec2020. The patient was given the vaccine at 11 am and her symptoms started probably at around 21:00 (9 pm). Patient further stated she received vaccine on 23Dec2020 around 11am and developed side effects of sore throat, fatigue/general malaise that evening. She couldn't find any data specifically reporting on sore throat. She was wondering if she should get tested for covid. Investigation assessment was no. The outcome of the events was unknown.
30 2021-01-04 pain in extremity Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site... Read more
Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 19Dec2020 19:15 at single dose on right arm for COVID-19 immunization in hospital. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced still having pain in right arm a week after injection, warmth/redness and hardness of injection site from 19Dec2020 19:15. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. The information on the batch number has been requested.
30 2021-01-05 tingling 1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambul... Read more
1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambulates to stretcher for further evaulation of clinic staff, FNP. Patient reported no previous adverse reaction to vaccines, but did note an anaphylactic nut allergy. Pt reported a milder version of the symptoms she is experiencing today after her initial vaccine Dec 17, 2020. Initial HR 64 SPO2 74% room air(employee wearing dark fingernail polish and reporting tingling in her hands) Pt instructed to breath slowly in through nose, out through mouth. 1225 BP 150/95 HR 85 SPO2 99% Pt given some water and crackers and reports eating NO food today other than a few cookies. Pt reports feeling better, color has now returned to pt. 1235- BP systolic 180s. pt advised to be seen in the ED for further evaluation. 1240 patient taken to ED by this RN; FNP; and second RN for further evaluation. 2L SPO2 put on pt en route based on previous low oxygenation. 1245- Pt arrived in ED, pt began reporting blurred vision; handoff to ED staff. Evaluated by ED staff, medicated with 1L NS bolus, 125mg IV Methylprednisone; 20mg IV Famotidine, 50mg IV Benadryl. 1640-employee reported to ED complete resolution of symptoms . Employee discharged from ED with prescription for an Epi-pen and prednisone.
30 2021-01-05 pain in extremity 15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. F... Read more
15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. Felt like I could not get up or do anything.
30 2021-01-05 dizziness At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer tha... Read more
At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer that she had a strong metallic taste in her mouth. It started 10-15 minutes after the injection. Denied all other symptoms that could be considered a side effect or allergic reaction to the vaccination. Advised patient she could stay later for further observation. Patient declined to stay. She felt fine otherwise. Patient was further advised if develops shortness of breath, or throat tightening to call 911 immediatley. Patient verbalized understanding. She indicated that she does have an epi pen due to allergies and will use it if necessary. Called patient at approximately 1830. She informed writer that she did have the strong Metallic taste in her mouth that started 15 minutes after the immunization and it lasted for about 1 hour. She reports that she was slightly light headed once she got home. Patient is not sure if it is due to starting night shift last night or if it was from the vaccine. Patient encouraged to increase her water intake. She was also encouraged to call PCP's office if light headedness does not completely resolved. If develops life threatening symptoms, to call 911. She was in agreement with plan. Writer will completed VAERS report tomorrow.
30 2021-01-05 tremor Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until... Read more
Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.
30 2021-01-05 pain in extremity I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itch... Read more
I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itching but not at the injection site, lower. then my eye started itching a little later. I got scared and went to the UC and they told me to take Benadryl. It was just for a day after I took the Benadryl the next day all was back to normal.
30 2021-01-05 migraine, dizziness Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fat... Read more
Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140, expiration date unknown) via an unspecified route of administration on 29Dec2020 at 12:30 PM (at the age of 30-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. The patient's medical history was not reported. No information was reported regarding allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient answered "yes" when asked to list any other medications she had received within two weeks of vaccination but did not list those medications. The patient stated that she experienced lightheadedness on 29Dec2020 "immediately after vaccine." About twenty-four hours later, on 30Dec2020 at 13:00 she experienced "SEVERE" diarrhea/urgency, nausea, fatigue, fever of 101 and migraine. The patient did not receive any treatment for the events. The clinical outcomes of lightheadedness, severe diarrhea/urgency, nausea, fatigue, fever of 101 and migraine were reported as recovering. The patient underwent lab tests and procedures which included body temperature: 101 on 30Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.
30 2021-01-05 lightheadedness, dizziness Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-... Read more
Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-syncopal. HR radial 120 bpm, BP 145/91 with HR 111 with BP cuff. Able to be released, feeling better. Recheck of BP 137/84, HR 88 bpm.
30 2021-01-05 pain Redness and swelling at injection site. Soreness like a bruise. Redness started about the side of a ... Read more
Redness and swelling at injection site. Soreness like a bruise. Redness started about the side of a nickel and progressed over the next 6-8 days to the size of a baseball. Localized swelling of that area was noticeable but not alarming. At two weeks the redness had completely resolved leaving just a nickel sized bruise. As of today 1/6/2021, everything has resolved. - Sought out no medical treatment for condition, just monitored at home.
30 2021-01-05 dizziness severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (pa... Read more
severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 03Jan2021 14:30 to 03Jan2021 14:30 as single dose for COVID-19 immunization. Medical history included allergies to latex, psoriatic arthritis, asthma, migraines and COVID19 prior vaccination. The patient's concomitant medications were not reported. The patient previously took Vicodin, Codeine, Imitrex and experienced allergies. On 03Jan2021 15:00, the patient got severely dehydrated, sweaty, dizzy. The outcome of the events was recovered. The patient does not received treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
30 2021-01-06 pain 13 hrs post vaccination started with fever (101), body aches and chills. Today just fatigue
30 2021-01-06 pain 13hrs post vaccination fever of 101, body aches,fatigue. today just fatigue
30 2021-01-06 pain Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 h... Read more
Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 hours
30 2021-01-06 pain in extremity, pain Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm... Read more
Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm for 60 hours
30 2021-01-06 pain For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after... Read more
For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after the injection, symptoms including headache, body aches, fatigue lasting 24 hours.
30 2021-01-06 pain in extremity Headache, arm pain, and chill
30 2021-01-06 lethargy Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint ... Read more
Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
30 2021-01-06 migraine Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migrai... Read more
Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migraine meds. Nothing helped, it was relentless. I am still having some pain but not as severe. I did not seek treatment as I hate the shots they used to do before my Topamax was prescribed. I had been migraine free for a little over year before this shot.
30 2021-01-06 pain Nausea, fever, chills, body aches
30 2021-01-06 pain Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 17 hours post vaccination, I woke with moderate ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 17 hours post vaccination, I woke with moderate body aches, moderate headache, moderate congestion, mild chills (NO fever), mild nausea, and significant overall fatigue. Symptoms ongoing for 8 hours, however chills and nausea are gone.
30 2021-01-06 dizziness SORE THROAT, LIGHT HEADINESS; TREATMENT: GAVE 25MG OF DIPHENHYDRAMINE
30 2021-01-06 dizziness Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at ... Read more
Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at the injection site. 3 days after until present: major fatigue.
30 2021-01-06 pain When vaccine was administered, seemed high on my arm. I had immediate soreness and shoulder discomf... Read more
When vaccine was administered, seemed high on my arm. I had immediate soreness and shoulder discomfort, I was told this was normal. It continued to progress and I eventually had decreased ROM, weakness and sharp shooting pain in my shoulder. Working at OI, I consulted provider, xrays were obtained and I was evaluated. He strongly suggested an MRI be obtained as well. That was completed the same day as my evaluation on 12/31/2020 (1 week and 2 days after the vaccine was administered). The provider informed me that they have had patients with similar situations that were evaluated for frozen shoulder after having a vaccine d/t administration site and vaccine going into subacromial space. He does report that this was my case/situation, upon my exam, I had severe inflammation with this as well-he is now having me follow up for a surgical consultation for my shoulder to be repaired. Today's date is 1/7/2021, I have these same ongoing symptoms that have continued since day of administration, without diminishing in severity. He is unable to provide an injection d/t my upcoming second dose of the COVID vaccine this next week, 1/12/2021. He strongly suggests that my 2nd vaccine be administered elsewhere-advised NOT be administered in the same shoulder OR in opposite to cause these symptoms to flare. He advised in gluteus if possible to avoid any further issues if at all possible.
30 2021-01-06 pain fever, body aches
30 2021-01-07 pain in extremity, pain Fatigue, body aches, chills, very sore site extremity all last about 24 hours, rigid neck, headache
30 2021-01-07 pain Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous r... Read more
Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered. Information about lot/batch number has been requested.
30 2021-01-07 pain Generalized body aches, malaise, tachycardia, nausea, headache, sweats. Intermittently for 48 hours,... Read more
Generalized body aches, malaise, tachycardia, nausea, headache, sweats. Intermittently for 48 hours, worse at night.
30 2021-01-07 tingling Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from ... Read more
Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering. Information on the Lot/Batch Number has been requested.
30 2021-01-07 pain Mild chills - onset 8-12 hours after Body aches - onset 8-12 hours after Fatigue - onset 8-12 hours... Read more
Mild chills - onset 8-12 hours after Body aches - onset 8-12 hours after Fatigue - onset 8-12 hours after
30 2021-01-07 numbness, tingling My jaw, cheeks and wrists went numb. It lasted around 30-40 minutes and then went away.
30 2021-01-07 pain in extremity Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next ... Read more
Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day. The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.
30 2021-01-07 pain in extremity, pain Pain from left arm and up to left shoulder Lymph node is enlarged and tender Diarrhea Body Aches
30 2021-01-07 difficulty speaking Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and ... Read more
Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and Xyzal 5mg. Shortly after complained of hoarseness. No respiratory, GI or cardiovascular symptoms. ENT consulted. patient observed for 3 hours.
30 2021-01-07 dizziness Patient received the Covid-19 vaccine. 10 min after the vaccine she reported a feeling that her hear... Read more
Patient received the Covid-19 vaccine. 10 min after the vaccine she reported a feeling that her heart was racing, felt light headed, no throat tightness. Her initial b/p was 150/95 HR 145 sao2 100% Slightly pale in appearance. After about 5 minutes she reported feeling better, she drank water, ate pretzels. She was observed to a total of 30 minutes. Recheck of her B/P 144/80 HR 76 100 % sao2 . Pt left on her own accord Ambulatory. She will follow up in the ED if her symptoms return or for any concerns.
30 2021-01-07 tremor Pfizer-BioNTech COVID-19 Vaccine EUA Patient received vaccine and shortly after was in a chair and ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received vaccine and shortly after was in a chair and experienced a syncopal episode. Pt was caught by staff member, and lowered to the floor. Patient reportedly had two syncopal episodes with brief periods of tremoring. Patient reportedly has prior syncopal history. Patient was A&O x4 when med response arrived. Patient was lying on floor with feet up on chair. Patient had unsteady gait and required multiple staff members' assistance. Patient was then transported to emergency department. While in the elevator, patient had her 3rd syncopal episode. Patient syncopal episode lasted for approximately 20 seconds. Patient regained consciousness and was brought into emergency department.
30 2021-01-07 pain Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fat... Read more
Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fatigue, soreness in the arm from injection
30 2021-01-07 pain in extremity, pain a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a c... Read more
a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a contactable nurse . A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Was notified on 04Jan2021 while the reporter scrolling on Facebook a friend of her who is a nurse who got the Pfizer COVID-19 vaccine and had side effects. Someone on had asked if the patient had any affects, patient stated a little fatigue and minor body aches. The reporter went back to and took a screenshot of the post that was dated from 23Dec2020. Patient was in her late 30's. Patient received vaccine on 23Dec2020 and she worked at Hospital name. This then triggered her to look into her other nurse friends. Apologizes for not having much information to provide on patient, she hasn't spoken to patient in 6 years. Mentioned that post only mentioned her arm was a little sore, but that was with any vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
30 2021-01-07 tenderness generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surroun... Read more
generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surrounding site of injection.
30 2021-01-07 pain left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore wh... Read more
left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest; left armpit is noticeably more swollen than right armpit; swollen, hard, lymph node which is not fixed when I palpate it; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 22Dec2020 at 12:00 at the age of 30 years at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks and she did not receive other medications in two weeks. Relevant medical history included allergy to sulfa based medication. Concomitant medications were none. On 29Dec2020 at 17:00, the patient experienced left deltoid was sore, left armpit was sore, soreness was radiating down her left side and into her left chest, left armpit was noticeably more swollen than right armpit and swollen, hard, lymph node which was not fixed when she palpated it. The patient reported that for 2 days after the vaccination her left deltoid was sore which went away. Then, approximately 7-8 days after the vaccination, she noticed her left armpit was sore. This has persisted and the patient could feel a swollen, hard, lymph node which was not fixed when she palpated it. Her left armpit was noticeably more swollen than her right armpit (which wass normal appearing). It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient did not receive corrective treatments for the reported events. At the time of the report, she had not recovered from the events. The information on the lot/batch number has been requested.
30 2021-01-07 dizziness, pain light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek med... Read more
light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek medical attention.
30 2021-01-07 weakness shortness of breath/progressed until I went to urgent care; I started to really bad cough and then i... Read more
shortness of breath/progressed until I went to urgent care; I started to really bad cough and then it actually got worse and worse; I was so weak like I am breastfeeding, I couldn't even hold my baby; extreme fatigue; I couldn't stay awake for more than a few hours at a time; Headache; lung problem; This is a spontaneous report from a contactable physician (the patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EH9899, via an unspecified route of administration on 16Dec2020 13:00 at single dose for COVID-19 immunisation. Medical history included history of reaction to mango (like face swelling and just a rash) and then gluten intolerant: if she eat it she doesn't have difficulty breathing. She never had problems with asthma in the past. The patient previously took BENADRYL for shortened like when she had a reaction with mango many years ago. In the past the patient had problems with cold and problems having bad cough that linger but she never needed Albuterol or steroids before. The patient had flu vaccine a month before, administered in deltoid left. The patient's concomitant medications were not reported. The patient experienced extreme fatigue on 19Dec2020 with outcome of recovering, shortness of breath/progressed until she went to urgent care on 21Dec2020 with outcome of recovering, She started to really bad cough and then it actually got worse and worse on 21Dec2020 with outcome of recovering, She was so weak like she was breastfeeding/She couldn't even hold her baby on 19Dec2020 with outcome of recovered on 20Dec2020, She couldn't stay awake for more than a few hours at a time on Dec2020 with outcome of unknown, headache on Dec2020 with outcome of unknown, lung problems on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included chest x-ray: normal on unspecified date; SARS-COV-2 test: negative on 23Dec2020. The vaccine was administered at Hospital Facility. The patient was treated with steroids (20mg for 5 days) and an albuterol inhaler (2 puff every 4 hour). The events required visit to Emergency Room. The events were non serious.
30 2021-01-08 dizziness Dizziness, increased heart rate, feeling like fainting, and headache.
30 2021-01-08 pain Headache and body pain beginning following morning, progressive throughout day adding chills/sweats ... Read more
Headache and body pain beginning following morning, progressive throughout day adding chills/sweats by 2pm which resolved by about 10 pm. Residual minor headache next day
30 2021-01-08 pain, pain in extremity Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causi... Read more
Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causing me pain to raise my left arm. Around 5 pm the same day, I started having body aches and had the chills. Then around 8pm I spiked a fever which reached up to 102.0 Fahrenheit, which I treated with Tylenol. In the morning (1/9/2021) the fever returned at 101.2 Fahrenheit, which I treated with Tylenol again.
30 2021-01-08 dizziness, tingling, pain in extremity, feeling hot Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately afte... Read more
Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.
30 2021-01-08 pain severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints a... Read more
severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.
30 2021-01-09 pain At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I ha... Read more
At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I had muscle soreness and aching. I went home and slept after working night shift. I woke up at 11 am, 17 hours post vaccine, and had a 102.4 F fever, chills, body aches and headache. At 3pm I still had 102-103F fever and called employee health and in which was directed to take Tylenol or Advil. I took 600mg Advil, and my fever broke at 8 pm, 26 hours post vaccine. That night my fever returned 102-103 F, I continued to take Advil. I took Advil around the clock, but let it lapse in dose Saturday evening 50 hours after receiving my vaccine. I then had a 101.5 F temp, I waited and it continued to rise, at midnight tonight, 30 mins ago, I took 600 mg Advil
30 2021-01-09 pain Chills, Fever (103.6), body aches, fatigue
30 2021-01-10 pain in extremity Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5... Read more
Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5 day
30 2021-01-10 tingling, dizziness, numbness At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they wer... Read more
At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they were on fire. The next morning I had chills, severe joint pain, fatigue, dizziness, nausea, and rash/ redness on my face (cheeks, nose, forehead). The next day (Sunday, the 10th) I felt much better but still a bit of joint pain and fatigue. Today (Monday the 11th) I felt fatigued, with. A resting heart rate of 90 according to my fitbit. I had some numbness/tingling in my right arm, dizziness, and felt fatigued. Towards the end of today I felt better but still have some pain in lower back and neck.
30 2021-01-10 dizziness Became lightheaded and dizzy , syncopal.VSS, MD assessed and transported to Clinic for observation
30 2021-01-10 pain Fever, Body aches, Headache
30 2021-01-10 lethargy, dizziness, numbness Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling fa... Read more
Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling faint, lethargy. Was wheeled to ED where they left me in the waiting room for two hours, not seen by a provider, before being told I was "fine" and sent home. On 1/9/2020 I began experiencing widespread bodily itch, no hives or swelling that included in and around my mouth. Took cirtirizine and symptoms were alleviated.
30 2021-01-10 pain Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach... Read more
Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach malaise
30 2021-01-10 dizziness, tremor Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well ... Read more
Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well as muffling in my right ear. My hands and feet became clammy. A small fan helped subside symptoms momentarily. Within minutes my lower extremities became shaky. I developed chills and felt faint. VS were measured. I was hypertensive (BP 134/100, baseline BP usually runs 110/80s). I developed intermittent tachycardic and heart palpitations, with a max HR of 124. Symptoms lasted approximately 1hour post vaccine administration. I work at a COVID testing site, chances of me being exposed to COVID-19 are high. I was not tested prior to receiving either dose of the vaccine; however, I have remained asymptomatic for the duration of the series.
30 2021-01-10 dizziness, pain body aches, chills, dizziness, headache. Improving.
30 2021-01-10 pain fever of 100.9, swollen lymph nodes, body aches, joint pain
30 2021-01-10 pain in extremity, pain fever up to 102 body aches arm pain
30 2021-01-10 numbness hives- like breaking out on fore head a lot of swelling in face numbness glands swollen under tongue
30 2021-01-10 numbness, tenderness left hand numbness, then progressed to tenderness under left arm, around deltoid, radiates to back, ... Read more
left hand numbness, then progressed to tenderness under left arm, around deltoid, radiates to back, swelling. Went to Urgent Care. RX Tylenol, cold/hot presses
30 2021-01-11 dizziness 3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improve... Read more
3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improved within 2-3 mins, cleared within 5-10 mins. No further reaction.
30 2021-01-11 pain, dizziness Body aches, HA, dizzy, back/neck/ aches
30 2021-01-11 pain, pain in extremity Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/2... Read more
Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/28/2020 at 2100. Took cold/flu medicine
30 2021-01-11 pain Headache, body ache, fever, fatigue. Improving.
30 2021-01-11 pain Malaise, fever, chills, headache, body aches
30 2021-01-11 migraine Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the P... Read more
Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications. The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be. Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.
30 2021-01-11 pain in extremity Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started w... Read more
Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started with burning sensation in the area of where the vaccine was administered. Soon after, within the hour, the area became erythematous and warm. She reported her whole left arm felt "achy". Patient took ibuprofen 600mg at 1pm as well as iced the area. She was evaluated by writer at 2:15pm. The area was noted to be erythematous, warm, and mildly swollen. The redness was outlined with skin marker and noted to be 15cm wide and 13cm in height. She denied any other symptoms.
30 2021-01-11 pain in extremity Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that s... Read more
Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that she took Motrin for this and is not sure if this is helping.
30 2021-01-11 dizziness, vertigo Vertigo sx, dizziness, tinnitus , sx are improving.
30 2021-01-11 tingling, dizziness, migraine, pain in extremity Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball lik... Read more
Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball like swelling at peak of swelling beginning Thursday evening through Saturday, inability to raise, hold, grasp or use arm for 2 days after injection, consistent fever for 36 hours/intermittent fever through Saturday, tightness in chest (relieved with inhaler every 2 hours) for 36 hours, tingling and phantom pain along left side of body and face, excessive exhaustion, dizziness and unfocused thoughts 48 hours, persistent migraine for 36 hours, intermittent headaches continuing with chills and nausea. Worse symptoms were 24-72 hours after injection, more mild side-effects (intermittent headache, nausea and chills) continuing through today.
30 2021-01-11 pain, pain in extremity aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a sp... Read more
aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.
30 2021-01-12 pain in extremity, pain 1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 ar... Read more
1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 around 7am with generalized malaise and severe fatigue. Spent most of the day in bed. Fevers on and off throughout the day with Tmax of 101.4. Some mild body aches. Sore arm with itching at the injection site. Lump at injection site. Had to call off of work. Loss of appetite. 1/9/21: Afebrile the whole day. Moderate fatigue in the morning. Overall felt better by the afternoon. Sore arm continued with itching and lump remaining at the injection site. 1/10/21: Overall felt better, arm soreness and itching at injection improving. 1/11/21: Mild fatigue. No arm soreness. Itching improved. Lump at injection site improving. Mild body aches in the evening. 1/12/21: Mild fatigue. 1/13/21: No arm soreness, itching and lump at injection site gone.
30 2021-01-12 pain, pain in extremity 1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and b... Read more
1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and body aches
30 2021-01-12 pain 2 hours after vaccine, felt nausea and aching in neck, like my blood pressure was elevated, hot flas... Read more
2 hours after vaccine, felt nausea and aching in neck, like my blood pressure was elevated, hot flashes. stopped after about an hour, returned again in the evening, again lasting about an hour, and did not come back after.
30 2021-01-12 pain, pain in extremity 2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches,... Read more
2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches, joint pain 2am continued fever despite fever reducers 6am (day after) continued fatigue, arm soreness reduced 12pm continued low grade fever -99.6-100, fatigue 6pm continued low grade fever, fatigue 6am (2 days after) improvement in symptoms 12pm return of low grade fever, and fatigue. continued soreness in arm
30 2021-01-12 pain Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing p... Read more
Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing pain and swelling at injection site.
30 2021-01-12 pain Body aches, chills, fatigue
30 2021-01-12 dizziness, pain Chills, body aches, joint pain, fatigue, dizziness. I took ibuprofen 400mg q6 with minimal effect. I... Read more
Chills, body aches, joint pain, fatigue, dizziness. I took ibuprofen 400mg q6 with minimal effect. I felt much better by my second day after the vaccine but still with fatigue, dizziness and joint pain. By the third day after I felt back to normal.
30 2021-01-12 pain Extreme fatigue 101 degree fever Body aches
30 2021-01-12 pain Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got t... Read more
Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got the COVID vaccine and is currently breastfeeding; female patient who just got the COVID vaccine and is currently breastfeeding; This is a spontaneous report from a contactable nurse (patient). This nurse reported for both mother and baby. This is maternal report. A 30-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: Elt9899; expiration date: not known), via an unspecified route of administration on left arm on 19Dec2020 10:00 at single dose for covid-19 immunization, administered at workplace clinic. Medical history included childbirth in Jul2020 and currently (ongoing) breastfeeding. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included norethindrone (NORETHINDRONE [NORETHISTERONE]) and unspecified prenatal vitamin (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested with covid-19 since the vaccination. On 19Dec2020 10:00, the female patient who just got the COVID vaccine and is currently breastfeeding. On 19Dec2020 18:00, the patient experienced fever for 8 hours, max 101.7; chills and body aches for 30 hours; and injection site pain for 48 hours. The reported events were non-serious. There was no treatment received for the events fever, chills, body aches, and injection site pain. The outcome of the event 'fever' was recovered on 20Dec2020 02:00 (for 8 hours), of event "chills and body aches" was recovered on 21Dec2020 00:00 (for 30 hours), and of event "injection site pain" was recovered on 21Dec2020 18:00 (for 48 hours).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011500 baby case
30 2021-01-12 weakness, numbness, feeling cold I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the f... Read more
I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.
30 2021-01-12 numbness Mild facial numbness around mouth
30 2021-01-12 pain, pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue and arm soreness within a few hours turned into full b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue and arm soreness within a few hours turned into full body chills, aches, and a fever about 8hrs after injection. Symptoms were intense and lasted throughout the night with Tylenol only minimally reducing fever. All symptoms lasted for about 24hrs, after which I felt completely normal.
30 2021-01-12 pain in extremity The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6.... Read more
The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6. Overwhelmed with exhaustion and fatigue. Massive headache coinciding. My arm felt like I had tennis elbow and overall joint pain. Nausea and vomiting through the night. Went to bed about 9:30. Woke up with a fever of 99. Off and on fever and chills through Friday, 72 hours after initial injection. Finally resolved late Friday night.
30 2021-01-12 numbness c/o numbness left hand, states happened after 1st shot but was several hours later, declines Benadry... Read more
c/o numbness left hand, states happened after 1st shot but was several hours later, declines Benadryl, states makes her drowsy, states she will just monitor herself and return if it gets worse.
30 2021-01-12 pain chills; Tiredness; generalized body aches; fever 101.4; This is a spontaneous report from a contacta... Read more
chills; Tiredness; generalized body aches; fever 101.4; This is a spontaneous report from a contactable Nurse (patient). A 30-year-old non-pregnant patient female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1686),intramuscular at Right arm on 06Jan2021 08:15 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included covid-19 prior vaccination. Concomitant medication included levothyroxine and multivitamin. The patient experienced tiredness, generalized body aches, chills, fever 101.4 on 06Jan2021 20:00. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
30 2021-01-12 pain moderate chills, body aches, sweats, fever measured at 100.7F: occurred about 12 hours after injecti... Read more
moderate chills, body aches, sweats, fever measured at 100.7F: occurred about 12 hours after injection and lasted 8-10 hours
30 2021-01-13 weakness, pain in extremity, pain Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the v... Read more
Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the vaccine. Symptoms included left arm pain, back pain, aches/chills starting at midnight on 1/6/21 into 1/7/21. Headache lasted all day, slept intermittently all day, low energy and extreme fatigue. Was 13 weeks pregnant at the time of the vaccine.
30 2021-01-13 tremor, dizziness At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral fo... Read more
At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral forearms and bilateral hip area. I felt itchy all over. When I stood up, I felt palpitations and started to feel as if I was going to pass out. I sat down and I started to tremor and felt like it was hard to catch my breath. I took an antihistamine and took a puff of albuterol. I felt a lot better. At 10 AM in the morning, the hives have improved but i still feel some pruritus.
30 2021-01-13 pain in extremity Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss... Read more
Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss of taste. Day 2 post vaccination only loss of taste, slightly improved.
30 2021-01-13 tingling, dizziness Dizzy, tingling in left arm, chest tightness and heaviness, tongue feels weird
30 2021-01-13 pain in extremity Fatigue, Nausea, Arm soreness Currently pregnant: EDD 08/20/2021
30 2021-01-13 pain in extremity Fever 100.8, right arm soreness and fatigue. Treatment: Tylenol. Outcome: mild improvement
30 2021-01-13 pain, pain in extremity Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took... Read more
Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took 975mg of Tylenol when I got home in the evening. But 12 hrs later after the vaccine shot, i woke up with severe body aches, chills, headache. Then i took another 975mg Tylenol but 3 hours later I started having fever that?s on and off. My fever even went up to 102.5F and the headache is very bad that is not relieved by Tylenol.
30 2021-01-13 migraine, pain Migraine, stiff neck, and body aches
30 2021-01-13 dizziness Patient began feeling dizzy and nauseous about 2 minutes after vaccine administration. She couldn?t ... Read more
Patient began feeling dizzy and nauseous about 2 minutes after vaccine administration. She couldn?t stand without falling. 911 was called and she was taken to the nearest hospital
30 2021-01-13 pain Patient received her 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine: At approximately 18:00 by RN.... Read more
Patient received her 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine: At approximately 18:00 by RN. Patient walked out of the vaccination room after her 15 minutes observation period and did not complain of any symptoms. She walked to the main entrance and notified a clinic manager at the check-in desk that she was experiencing "chest pain." Clinic RNs came to observe and assess the patient. The patient communicated with no displays of distress. When asked what type of chest pain, she stated "heaviness pressing on her chest, localized on the left side and on the upper chest area." Patient denied pain radiating down arm and denied jaw pain. Patient denied SOB and had no signs and symptoms of respiratory distress. She was escorted to the ED via wheelchair at 18:33. The ED note states that symptoms were most likely related to anxiety (patient mentioned she was anxious about receiving her second dose) and as patient reported symptoms completely resolved, she was discharged home from the ED at 19:01.
30 2021-01-13 dizziness Quickly after receiving vaccine patient began feeling lightheaded/dizzy then progressed to nauseated... Read more
Quickly after receiving vaccine patient began feeling lightheaded/dizzy then progressed to nauseated and feeling the need to vomit. Patients temperature increased slightly to 99.4. Placed a cool washrag on neck and gave Diphenhydramine 25mg at 12:15pm (patient stated had Benadryl at 6am at home before coming to work). Patients blood pressure was taken by parent who is a nurse at Woodridge 122/86. At 12:57pm patients temperature returned to 97.4 and patient was improving. Patients parent gave Zofran for the nausea/vomiting feeling at 1pm. Patient was feeling better but still dizzy and patients parent took the patient home at 1:18pm.
30 2021-01-13 pain Temp of 101.5, nauseous, fatigue, body aches, dry heaving
30 2021-01-13 pain in extremity, dizziness Upper arm soreness and dizziness both started 5.5 hours after receiving vaccine.
30 2021-01-13 dizziness within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated wi... Read more
within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated with Benadryl. solumedrol. sx resolved. Observed for 4 hrs. d/cd to home
30 2021-01-14 tenderness 15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left ... Read more
15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left arm became super tender, I woke up with significant joint pain in my right knee. I almost couldn't walk, it was chronic pain when I tried to walk. It lasted about 24 hours and went away. I did inform my OB.
30 2021-01-14 feeling hot 20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure... Read more
20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake. Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.
30 2021-01-14 numbness Chest pain, predominantly on the right side, numbness in right arm and increased heart rate. Symptom... Read more
Chest pain, predominantly on the right side, numbness in right arm and increased heart rate. Symptoms started about an hour after the vaccine. Each episode lasts 30-40 mins then subsides and symptoms go away completely. I had 3 episodes of these symptoms the first day and so far 3 the second day. My doctor recommended I go to the emergency room. Based off my EKG, vitals, and family history there was no reason to believe that the episodes were causing any heart abnormalities.
30 2021-01-14 pain Chills, body aches, neck stiffness
30 2021-01-14 feeling cold Cold Symptoms , headaches , fever, chills
30 2021-01-14 feeling of body temperature change, pain Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not fe... Read more
Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not feeling well. I woke up at 10 pm sweeting and body aches. All through the night I was hot then cold. I developed a temperature of 100.8. Had no appetite in the morning. At 7:30 am I started to feel better. Had head ache through out the day Thursday.
30 2021-01-14 weakness Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, ... Read more
Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown unable to locate or read the details) via an unspecified route of administration at Left arm on 23Dec2020 14:15 at single dose covid-19 immunization. Facility type vaccine was Hospital. No known allergies and no other medical history. Concomitant medication included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), colecalciferol (VITAMIN D). No other vaccine in four weeks. The patient experienced itchiness, hives, wilts, abdominal pain on 01Jan2021 23:45. The events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination and covid was not tested post vaccination. Treatment Benadryl was received for the events. The outcome of the events was recovered in Jan2021. Information about lot/batch number request.
30 2021-01-14 pain No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21. On 1/... Read more
No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21. On 1/14/20 pt reports fever 101.6, chills, body/muscle aches. These symptoms improved during day on 1/14/21. Pt reports evening of 1/14/2021 she began feeling like her skin hurt, burning feeling. On 1/15/2021, pt woke to hives across chest, abdomen, axillas, underside of arms and lateral torsos, scalp and posterior neck. Pt reports hives are present in area of painful skin the day prior. Pt reports hive were not initially itchy, but are at time of evaluation. Pt provided with care instructions for urticaria/hives, benadryl & OTC Allergy tablet instructions. She was also provided for s/s to watch-worsening hives, swelling,
30 2021-01-14 tingling Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives coveri... Read more
Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives covering face, chest and arms. Given 50mg Benadryl and 40 mg Pepcid. Symptoms resolved a little over an hour post injections
30 2021-01-14 dizziness, lightheadedness Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report fro... Read more
Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report from a non-contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730), via an unspecified route of administration on 08Jan2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergies. The patient was vaccinated in a hospital. The patient was not administered any other vaccine in four weeks and had no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. It was reported that the patient experienced severe dizziness, almost blacked out, nausea and elevated heart rate on 08Jan2021 at 4:00 PM. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events were reported to be non-serious.
30 2021-01-14 vertigo Severe vertigo like episode requiring emergency room visit. Medicated with meclizine x2 and zofran w... Read more
Severe vertigo like episode requiring emergency room visit. Medicated with meclizine x2 and zofran with no relief of symptoms. Attempted Brandt-Daroff maneuver with no relief of symptoms. Medicated with valium with no relief. Medicated with IV Bendadryl, IV Toradol, and IV Reglan with moderate relief.
30 2021-01-14 pain When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; ... Read more
When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; This is a spontaneous report from a contactable other health professional (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 06:45 AM at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was no. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number and expiration date), via an unspecified route of administration on 18Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. The patient experienced chills, aching and fever 10 hours later at 08Jan2021 18:30. When the patient got sick she got a rash that didn't itch all over her body and it happened 24 hours after the vaccine, on 09Jan2021. No treatment was received for all events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on lot number/batch number was requested.
30 2021-01-14 dizziness, difficulty speaking chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after rece... Read more
chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.
30 2021-01-14 pain severe pain in her lower left side; Abdominal pain that feels like a cramp at first but the pain int... Read more
severe pain in her lower left side; Abdominal pain that feels like a cramp at first but the pain intensifies when you try to move.; This is a spontaneous report from a contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 05Jan2021 at 12:00 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not diagnosed of COVID-19 prior to vaccination. The patient did not have any other vaccines in the last four weeks. The patient's concomitant medications were not reported. The patient experienced severe pain in her lower left side on 07Jan2021. The patient also reported abdominal pain that feels like a cramp at first but the pain intensifies when you try to move on 07Jan2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination. Information about lot and batch number was requested.
30 2021-01-15 pain Chills, body aches, sweats and nausea began about 8 hours after vaccination. Was received. Symptoms... Read more
Chills, body aches, sweats and nausea began about 8 hours after vaccination. Was received. Symptoms gradually got worse as the day went on. The symptoms we the worst at around the 24hr post vaccine mark. It is now almost 40 hours post vaccine and symptoms have improved but still remain. Symptoms improved with ibuprofen and Tylenol and rest.
30 2021-01-15 dizziness Dizziness, nausea, headache around 38hr s/p vaccine
30 2021-01-15 pain Extreme chills, fever, body aches and swollen lymph node by neck on same side of injection. Lymph no... Read more
Extreme chills, fever, body aches and swollen lymph node by neck on same side of injection. Lymph node is painful at touch.
30 2021-01-15 pain, tenderness Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately ... Read more
Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately 12 hours later. Significant lymphadenopathy in the left axilla (same arm as injection site), with tenderness, generalized aching, and obvious swelling and fullness to palpation of the left axilla. Body aches were treated with Tylenol and resolved in 24 hours. Lymphadenopathy in the left axilla persisted until 11/17/21, with improvements in severity of ache and size of swelling noted on 11/16/21.
30 2021-01-15 tingling Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 210... Read more
Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 2100 the same night, rapidly progressing paresthesia of complete left face without obvious facial palsy yet (numbness happened over the course of about 30min to the point where I had no perception of touch in the left face). At this point I took 60mg of prednisone and went to bed. When I woke up, the paresthesia/stiffness was less and progressively so since finishing a course of prednisone. Concerned that this could have been a bells palsy reaction to the vaccine.
30 2021-01-15 pain Severe headache, fever of 103.9, tachycardia, lymphadenopathy, body aches, chills, fatigue, and shor... Read more
Severe headache, fever of 103.9, tachycardia, lymphadenopathy, body aches, chills, fatigue, and shortness of breath. Advised to go to Urgent Care on 1/14/2021. Was given fluids and toradol and told to continue to monitor and treat symptoms at home.
30 2021-01-15 pain swollen lymph nodes in left axilla, body aches, headache, low grade fever
30 2021-01-16 tremor, weakness, dizziness 2:30PM Chest pains, weakness, dizziness, feeling shaky. 6:20pm Tachycardia, hypertension, fever, fa... Read more
2:30PM Chest pains, weakness, dizziness, feeling shaky. 6:20pm Tachycardia, hypertension, fever, fainted, whole body went limp and unable to keep head up. 8:30 able to use arms again and feel them 10:30pm able to use legs and walk again
30 2021-01-16 pain Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very... Read more
Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very sore throughout the day my entire body became extremely sore and I developed an ear ache and a headache and I am very fatigued. Today is the 17th of the month and that your aching headache still has not always go away. I?m not sure if this is a normal reaction or not.
30 2021-01-16 migraine, pain Migraine Body aches Large red painful lump at injection site Exhaustion
30 2021-01-16 dizziness Woke up at 3 am with severe chills, went to the bathroom to check temperature. Got incredibly nauseo... Read more
Woke up at 3 am with severe chills, went to the bathroom to check temperature. Got incredibly nauseous and light headed. Passed out on the bathroom floor and hit my chin. Had to get stitches, fluid, and CT.
30 2021-01-17 migraine Migraine, Sore Throat
30 2021-01-17 pain, pain in extremity fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site a... Read more
fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; Started having chills; Severe headache; collapsed on the way back to bathroom and was unable to get up for about 20 minutes; tachycardia; extremely fatigued entire day; This is a spontaneous report from a contactable Pharmacist who reported for herself. A 30-year-old female patient received her second dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number Ej1685) at a single dose at 09:45 AM 07Jan2021 at left arm for Covid-19 immunization in a hospital. The patient had her first dose of Pifzer Covid-19 vaccine on 21Dec2020 at 12:00 PM at left arm, and experienced very mild reactions which included mild pain at injection site and runny nose/sneezing day after vaccine. The paitent had a medical hisotry of rash to penicillin as a child. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to her first dose of Pfizer COVID vaccine. In the evening of second vaccine (around 17:00), pain and stiffness radiated from injection site all the way down arm, into breast, and middle of back. She started having chills. Around 10 hours after dose chills became somewhat violent despite being under 4 blankets. Severe headache also started. In the middle of the night to go to bathroom, she collapsed on the way back and was unable to get up for about 20 minutes. She also suffered from tachycardia overnight. her baseline heart rate runs in 60s- 70s, but was in 110s-120s (based on Apple Watch monitoring). Day after vaccine, she was extremely fatigue entire day and spent all but a few hours in bed. Arm pain mostly gone. Headache was very strong and persistent through the day. On second night chills not as bad but still occurred overnight. HR still elevated in 80s overnight. Morning of day 2 still had headache and fatigue. The patient did not receive any treatment for the events. The outcome of collapse and unable to get up for 20minutes, pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back was resolved, chills and tachycardia was resolving, headache, fatigue was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered that the events was non-serious.; Sender's Comments: Based on a chronological temporal association and known BNT162B2 vaccine safety profile, causality between events fainting, violent chills and severe headache and BNT162B2 ((Pfizer/ BioNTech Covid-19 vaccine) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-01-17 tremor injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering to... Read more
injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.
30 2021-01-19 pain 12 hours later - chills, fever, body aches; headache; joint aches; fatigue. Called Urgent Care and t... Read more
12 hours later - chills, fever, body aches; headache; joint aches; fatigue. Called Urgent Care and they had me take- Imotrix that I already had and tylenol and hydrated - lasted 36 hours. Symptoms resolved.
30 2021-01-19 feeling hot 30yo female with no documented allergies received COVID-19 Pfizer BioNTech vaccination, dose#1. Pat... Read more
30yo female with no documented allergies received COVID-19 Pfizer BioNTech vaccination, dose#1. Patient c/o feeling warm, blotchy across her face and chest. Stated she was really nervous about receiving the vaccine. Monitored for 45 minutes under direct observation of clinic staff. Initial SBP 156 and decreased to 120/80s. Denies nausea, drinking water. Remained on 100% RA. Blotches appear less bright. Asked to go back to work. No dizziness, ambulated to door without problems. Discharged to self and returned to work.
30 2021-01-19 pain About 12 hours after - chills, fever , headache, body aches, joint ache (like flu) - lasted 36 hours... Read more
About 12 hours after - chills, fever , headache, body aches, joint ache (like flu) - lasted 36 hours. I hydrated - Took Imitrex that I still had; Tylenol and was back to normal after 36 hours. Called Urgent Care
30 2021-01-19 pain, dizziness Body aches - particularly elbow, knees, and hands. Fatigue. Occasional light headedness. All sympt... Read more
Body aches - particularly elbow, knees, and hands. Fatigue. Occasional light headedness. All symptoms were gone by following morning!
30 2021-01-19 pain DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HE... Read more
DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HEADACHE, FATIGUE, INTENSE SORENESS AT INJECTION SITE/ AFTERNOON & NIGHT (1/12): MORE FATIGUE AND SOME NAUSEA. 2ND MORNING AFTER VACCINE (1/13): SOME FATIGUE AND LIGHT NAUSEA. 2ND AFTERNOON AFTER VACCINE (1/13): NO SYMPTOMS. TOOK TYLENOL (EXTRA STRENGTH) & ADVIL.
30 2021-01-19 pain Fever, chills, body aches, headache, fatigue. Improving.
30 2021-01-19 dizziness Patient with h/o hives from first dose (12/26/20) became lightheaded and dizzy 20-30 minutes after s... Read more
Patient with h/o hives from first dose (12/26/20) became lightheaded and dizzy 20-30 minutes after second dose. Received 25 mg Benadryl and Epi-Pen before being sent to the ED.
30 2021-01-19 dizziness Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Med... Read more
Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Medium
30 2021-01-19 dizziness The patient received her first dose of the Pfizer vaccine on 12/26/2020. Following the second dose o... Read more
The patient received her first dose of the Pfizer vaccine on 12/26/2020. Following the second dose of the Pfizer vaccine, the patient became lightheaded, dizzy, and wheezed 20-30 minutes after the injection. 25 mg Benadryl administered, along with Epi-Pen. The patient was transported to the ED.
30 2021-01-19 pain ~12h after vaccine administration, severe body aches, fever, fatigue, malaise, nausea and vomiting l... Read more
~12h after vaccine administration, severe body aches, fever, fatigue, malaise, nausea and vomiting lasting ~18h.
30 2021-01-20 numbness, weakness, dizziness Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous r... Read more
Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 15Jan2021 14:15 at SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included tachycardia, Pre-ventricular contractions, allergies to Latex, covid-19 (reported as covid prior vaccination: Yes). Concomitant medication included metoprolol and multivitamin. No other vaccine received in four weeks. On 15Jan2021 14:30, the patient experienced chest pains, dizziness, weakness. On 15Jan2021 18:20, the patient experienced cardiac event, paralysis, fever, numbness, chest pains. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. Information on batch/lot number was requested.
30 2021-01-20 pain body aches; full body chills; temp of 100.1; moderate headache; This is a spontaneous report from a ... Read more
body aches; full body chills; temp of 100.1; moderate headache; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (lot number unknown), via an unspecified route of administration in right arm, on 09Jan2021 08:00 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced body aches, full body chills, temp of 100.1 and moderate headache on 09Jan2021 10:00 PM. Treatment was received for the events included Tylenol, ibuprofen. The outcome of the events was recovering. Information on the lot/batch number has been requested.
30 2021-01-21 pain, migraine 1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and ac... Read more
1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and aches, severe migraine and fever of 101.2F. Continued through 1/14 and missed work. Returned to work on 1/15 still having fatigue, nausea and severe headache.
30 2021-01-21 numbness, seizure Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't... Read more
Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't feel 3 toes, lost consciousness.
30 2021-01-21 pain Received shot at 0610. Started feeling cruddy around 1600 w/ severe headache, neck pain, and shoulde... Read more
Received shot at 0610. Started feeling cruddy around 1600 w/ severe headache, neck pain, and shoulder pain, with overall malaise. Symptoms intensified at 2000 with severe rigors until ~0400 accompanied by body aches. Intermittent fevers experienced during that time as well. Next day, general malaise and severe body aches until ~1500; then subsided to mild headache and mild malaise. Post vaccine day #2 left with mild malaise, all other symptoms subsided.
30 2021-01-21 weakness, dizziness chest pain fever of 102.0, sore throat, headache, dizziness, weakness tiredness
30 2021-01-21 migraine, tremor, pain extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( nor... Read more
extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( normally 96.8, currently 100.8). Sweating. Shaking due to cold extremities. Migraine. Pain in lower back (kidney area), chronic and achey. Joint pain in legs/ hips. Nausea constantly. Feeling of overall pain and discomfort. exhaustion.
30 2021-01-21 pain fever (101.0) chills body Aches and joint pain when walking. headache and loss of appetite
30 2021-01-24 dizziness Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous rep... Read more
Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm at 17:15 on 11Jan2021 at single dose for COVID-19 immunization. Medical history included migraine and seizure. Concomitant medication included lamotrigine (LAMICTAL) and zonisamide (ZONEGRAN). Both received within two weeks of vaccination. The patient experienced passed out, chest tightness, dizziness, trouble breathing, and itching throat, all at 17:30 on 11Jan2021. No other vaccines received in four weeks. Facility type vaccine was in hospital. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received salbutamol (ALBUTEROL), steroids, diphenhydramine hydrochloride (BENADRYL), lansoprazole (PREVACID) and IV fluids for treatment. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
30 2021-01-24 pain headache, chills, body aches, temperature, fatigue, night sweats, 3 days
30 2021-01-25 tingling, pain, tremor ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWE... Read more
ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWEAT. WEDNESDAY NIGHT- SAME SYMPTOMS BUT 10X WORSE. UNCONTROLLABLE SHAKES, FEVER, FREEZING, ENTIRES BODY ACHES. TOOK TYLENOL, NYQUIL AND ADVIL.
30 2021-01-25 pain in extremity Arm pain, joint pain, treated with naproxen
30 2021-01-25 tingling, nerve pain, pain Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 min... Read more
Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 minutes every 30 minute or so) Tingling in my hands and finger tips.
30 2021-01-25 pain Temp 100.4 Ha Body Ache, nausea
30 2021-01-26 tingling Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/20... Read more
Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/2020 (solumedrol injections from rheumatologist in right knee and both shoulders), tingling in fingers, toes, & lips since 12/25/2020 (no treatment), psoriasis flare of face since 12/25/2020 (never experienced before reaching out to dermatologist) Low grade fever off and on 12/31/2020 until 1/11/2021
30 2021-01-26 pain Fever, chills, body aches, headache.
30 2021-01-26 pain in extremity, pain Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and bo... Read more
Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021. Information on the lot/batch number has been requested.
30 2021-01-26 pain Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and p... Read more
Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.
30 2021-01-26 pain Woke up with chills, fever of 100.8, moderate headache, and body aches. I took 1000 mg of Tylenol wh... Read more
Woke up with chills, fever of 100.8, moderate headache, and body aches. I took 1000 mg of Tylenol which brought the fever down to 98.2, however, headache and body ache remained. I took Tylenol in 1000 mg doses around the clock every six hours for 24 hours, and 24 hours later felt no more symptoms.
30 2021-01-28 dizziness Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness ... Read more
Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.
30 2021-01-31 pain My white blood count went really high; The first dose was on 28Dec2020 and the Lot: EH9899. The seco... Read more
My white blood count went really high; The first dose was on 28Dec2020 and the Lot: EH9899. The second dose 12Jan2021 at 7am, Lot: EL1284; Extremely achy/Body aches; Chills; Back hurts so bad that she can't lay down; Sweating; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the right arm, on 12Jan2021 07:00, at single dose, for COVID-19 immunization, in the hospital. The patient medical history and concomitant medications were not reported. The patient had no allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), via an unspecified route of administration, on 28Dec2020, for COVID-19 immunization and the patient had flu-like symptoms. The patient reported that with the first round of the vaccine, she had flu like symptoms. This time in Jan2021, with the second dose, it was more severe and if she didn't keep up with Tylenol, she was extremely achy, had chills, her back hurts so bad that she couldn't lay down, and sweating. The patient wanted to know if that was normal. The patient mentioned she called out of work for the rest of the week and left early on Tuesday. The patient stated that she had not been to the doctor at this point but when Tylenol wears off it was really ugly and would consider going. The patient stated that she was almost on septic. Her white blood count went really high on 12Jan2021 and was hospitalized from 16Jan2021. She was put on Cefepime, 2 gm per vial, gotten maybe 4 of them so far. Body aches was ongoing. Her blood work was getting better. The outcome of events white blood count went really high, extremely achy/body aches was not recovered.The outcome of other events was unknown. Follow-up (17Jan2021): New information from a contactable consumer (patient) includes: Reaction data (add event white blood count went really high, outcome of event extremely achy/body aches updated). This case has been upgraded to serious.
30 2021-02-03 feeling cold, feeling hot, dizziness, weakness I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off... Read more
I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
30 2021-02-03 tremor anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting fo... Read more
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
30 2021-02-08 weakness Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent... Read more
Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged. She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia. These things necessitated transfer. While at hospital, hematology was consulted. Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this. While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed. While there, DIC labs were trended/began to improve. Discharged on 1/5/21. Had f/u with hematology @ hospital on 1/12/21. No reason has been found as of yet as to why she became ill. Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use. Will f/u with heme in early Feb. Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness. She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC
30 2021-02-08 dizziness, tingling tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills... Read more
tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
30 2021-02-17 pain I basically had all of the symptoms of Covid. I exp nausea, diarrhea, 103. temp, chills(got fever un... Read more
I basically had all of the symptoms of Covid. I exp nausea, diarrhea, 103. temp, chills(got fever under control was gone in a day), body ache,congestion lasted 3 days. I went to the ER twice first time discharged to go home rest and second time told it might of been food poisoning,
30 2021-02-21 inability to speak Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of ... Read more
Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat
30 2021-02-22 vertigo, dizziness Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headach... Read more
Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headache. Dizziness lasting for more than 1 week. Vertigo still present after 7 days if laying in certain positions. Taking meclizine as needed for dizziness and motion sickness.
30 2021-02-23 tingling Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previou... Read more
Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previous rx to radio active iodine. Notes scratchy throat, tingling and puffy lips. Symptoms did not worsen over 60 minutes in observation. No difficulty breathing. Advised to take benedryl and seek medical attention if symptoms worsen. Patient left with her mother. RN called later in the evening, client confirmed sxs improved with Benedryl, feeling better.
30 2021-02-25 feeling cold Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from... Read more
Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from a contactable consumer reporting for herself. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 10Feb2021 at single dose in Left arm for COVID-19 immunisation. Medical history included coeliac disease from an unknown date. There were no Allergies to medications, food, or other products. The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), on 20Jan2021 at the age of 30-year-old at single dose in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Painful left arm (where vaccinated). She experienced flu like aches the day after vaccination as well as feeling cold on 11Feb2021. Since the vaccination, the patient had not been tested for COVID-19There was no treatment received for the adverse event. The outcome of events was recovered. The events were reported as non-serious.
30 2021-02-27 nerve pain 1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above righ... Read more
1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days 1/4/21 - Ganciclovir eye drops added to treatment course 1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received
30 2021-02-28 dizziness, pain, pain in extremity whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; ... Read more
whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
30 2021-03-02 dizziness extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-c... Read more
extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-contactable other health professional (patient). A 30-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 28Jan2021 14:30 at single dose for Covid-19 immunization in a workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included first dose of BNT162B2 lot number EL1284 on 01Jan2021 for Covid-19 immunization. The patient received other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced extreme stomach cramps, vomiting, dizzy, headache, chills. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.
30 2021-03-03 pain in extremity Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for... Read more
Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for herself). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration single dose arm left (at the age of 30) on 02Feb2021 for covid-19 immunisation. No other vaccine was received in four weeks. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness on 02Feb2021, minor fatigue on 02Feb2021. No treatment received. The events outcome was recovered.
30 2021-03-14 unresponsive to stimuli History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on ... Read more
History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care.
30 2021-03-14 numbness Numbing of left leg/Numbing of left side of face; This is a spontaneous report received from a conta... Read more
Numbing of left leg/Numbing of left side of face; This is a spontaneous report received from a contactable pharmacist (patient herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: EL3247 and expiry date: May2021) via an unspecified route of administration to left arm on 17Jan2021 12:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. She was administered vaccine about 12:30 on 17Jan2021 she sat there monitored for about 15 minutes. She reported the Numbing of left leg started while she was walking out, about 13:00 from her left leg down to her foot; her left arm was fine, there was no Numbing there or other areas of body or left side of body other than onset of Numbing of left side of face a little bit after onset of Numbing of left leg. She thought at first maybe it was from the way she had been sitting, but she had been sitting normal. The Numbing of left leg and Numbing of left side of face lasted for a couple of hours on 17Jan2021; resolved and she recovered completely as far as she is aware by 17Jan2021. She reported not serious for both events because it went away. She is due for her second dose on Sunday and is afraid to get second dose. Both events were recovered on 17Jan2021. No follow-up attempts are possible. No further information was provided.
30 2021-03-17 lightheadedness, dizziness Within 15-minutes of vaccination, the patient had a syncopal event preceded by nausea and lightheade... Read more
Within 15-minutes of vaccination, the patient had a syncopal event preceded by nausea and lightheadedness. EMS evaluated the patient on-site. The patient was pale, diaphoretic, and hypotensive (67/37). EKG (3/12): Sinus brady, rate 46 bpm, no ST elevation. FSBG (3/12): 89mg/dl. EMS administered 500mL IV saline. EMS transported the patient to Hospital Emergency Department. In the ED, the patient feels back at baseline and was normotensive (119/72). Patient stated they have a history of vasovagal response and vasovagal vomiting, but had never experienced a vasovagal syncope episode. Physician administered 0.5mg Lorazepam. The ED physician admitted the patient to the telemetry unit for vasovagal syncope due to patient's prodrome and prior history of similar near syncopal episodes. Inpatient attending agreed that the patient's vasovagal response may be secondary to poor PO intake with extreme stress. Patient's admission was less than 1-day and stated they were anxious to return home. Discharged with diagnoses of Mild leukocytosis, Vasovagal response, and Orthostatic hypotension secondary to dehydration.
30 2021-03-18 dizziness 1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to n... Read more
1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to needles in the past (did not seem like it was complete syncope to all needle sticks per RN). RN offered for her to lie down, but she said she felt ok sitting. She did not endorse any history of severe allergies or reactions to injectables in the past; she was asked the necessary questions prior to vaccination. We later learned she has Crohn?s and is on immunosuppressant Imuran for this disorder. 1023ish ? walked to checkout area 1025 - While sitting at the checkout registering for her second shot she started to feel faint and checkout staff called for help 1026 - RNs were getting the BP cuff on her. She appeared obtunded and slouching in her chair- eyes closed. Gentle sternal rub and she was able to open her eyes and tell us what her name was and ask to call her dad. BP 90/58. Cold cloths placed on her neck. Continuous pulse ox monitor placed, showing 99%. 1030 - Still drowsy and diaphoretic. Able to tell us that "she passes out when she gets shots" C/O nausea and vomited. Still in and out of awareness. NP is site coordinator is now present and suggests taking patient by wheelchair to safer and more private area for evaluation in SR Room. Patient able to stand and transfer to wheelchair, which we did slowly and carefully. 1034 ? Now in safer and more private area SR room with NP and RN and Dr. Firemen are here and assessing the scene with medic assessing patient. Ambulance in route, about 5 - 10 minutes out per radio communication. Checking BP every 2 minutes. Now is 68/44. C/O nausea and vomited. Pulse ox won?t pick up. Patient with decreasing LOC, eyes rolling back in head, unable to maintain posture seated, and not able to describe symptoms to us (unknown if she felt itchy but no obvious cutaneous manifestations). Unable to visualize oropharynx. 1037- BP 57/40. NP administered Epi pen 0.3 mg dose to L lateral thigh due to s/s of systemic allergic reaction/anaphylaxis including 3 known body systems: hypotension (cardiovascular), vomiting (GI), and decreased LOC (neuro). No IV fluids immediately available but were preparing to obtain. Staff getting cot for patient to lie down. Provider spoke with her mom on the phone and informed her of event. Mom confirmed that she has often before passed out with vaccines and blood draws. Dad was on his way to center and rerouted to ER. 1038 - BP 68/45 Talking to medics and able to tell them she ate breakfast and that she has a hx of Crohn's and takes a monthly injection. Informed provider that her dad was on his way. EMS team here to transport to ER. We were preparing to put her on a cot so help with her blood pressure/blood flow when she started to stabilize and EMS arrived with stretcher. 1040 - BP 97/53. Patient is now alert and talking to us. Says she has had syncope in the past ?but never anything like this.? 1041 - BP 115/53. Patient still alert and talking. Oriented x 3. 1042 - Transported to ER by EMS ambulance on stretcher. DEBRIEF: Somewhat atypical (no obvious cutaneous manifestations) and rapid, severe reaction. Ddx vasovagal vs anaphylaxis. Response to epi consistent with anaphylaxis reversal. Perhaps immunosuppressant medication contributed to severity and rapidity of reaction.
31 2021-01-01 pain in extremity, tingling A few hours after receiving the vaccine I noticed typical arm soreness associated with vaccines. Ho... Read more
A few hours after receiving the vaccine I noticed typical arm soreness associated with vaccines. However, this time I also noticed there was a cold tingling feeling in my arm, leg, and toes on the left side of my body (injection side). It happened on and off and lasted for a few minutes at a time. It was not bothersome and resolved within 24 hours. Soreness the next day was worse than with any vaccine received prior (including tetanus shot) and limited range of motion but did not interfere with activities of daily living.
31 2021-01-02 tingling, numbness, pain in extremity Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely... Read more
Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely resolved independently on days 4 and 5. On day 6, developed significant welt-like hives, intense burning and itching, and numbness/tingling of entire extremity. Also developed a non-pruritic, flat, diffuse, pinpoint rash to the trunk. Rash and itching resolved with Benadryl. Right upper extremity burning, pain, and numbness persist.
31 2021-01-02 balance disorder, vertigo Two days after receiving first dose of Pfizer COVID vaccine started feeling generally unwell. On the... Read more
Two days after receiving first dose of Pfizer COVID vaccine started feeling generally unwell. On the third day, started feeling progressively worse: dizziness upon standing and while standing (to the point I thought I would fall over) nausea, dry heaving, headache bordering on migraine, abdominal pain and a short period of appetite loss. Today (fourth day post shot) I called out of work and feel as if I?m on a tilt table while laying down, and will feel dizzy and nauseated immediately upon standing up. This is is spite of staying hydrated and eating a bland diet in order to not upset my stomach.
31 2021-01-03 dizziness 15 minutes after vaccine patient had light headedness, body chills and patient said she had a "rush ... Read more
15 minutes after vaccine patient had light headedness, body chills and patient said she had a "rush of blood feeling in her body". Vital signs remained stable and patient observed x 90 mins.
31 2021-01-03 pain Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body... Read more
Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body pain/back pain. I almost passed out putting pants on. A friend took me to an Urgent care they gave me Shot of tramadol and given Tylenol 3. They also did a test on my kidney. About 50 hours after the shot I was feeling better.
31 2021-01-03 pain PT REPORTED HYPOTENSION/BRADYCARDIC EPISODE, BODY ACHES, CHILLS, FEVER, MALAISE FOR 2.5 DAYS. PT WEN... Read more
PT REPORTED HYPOTENSION/BRADYCARDIC EPISODE, BODY ACHES, CHILLS, FEVER, MALAISE FOR 2.5 DAYS. PT WENT TO HOSPITAL FOLLOWING REACTION. SHE WAS NOT HOSPITALIZED, SEVERE SYMPTOMS RESOLVED WITH REST AND HYDRATION. CONSULTED WITH PCP AND MONITORED FREQUENTLY.
31 2021-01-03 pain in extremity Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours ... Read more
Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours
31 2021-01-03 numbness, dizziness Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart pro... Read more
Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart problems
31 2021-01-03 dizziness, numbness patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and th... Read more
patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and though she was going to pass out. Patient states she has needle phobia and has had this happen in the past.
31 2021-01-04 pain in extremity Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck... Read more
Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. No follow-up attempts are possible. No further information is expected.
31 2021-01-04 pain in extremity Extreme pain in arm for 72 hrs. Continued pain for 2 more days.
31 2021-01-04 tingling I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have ... Read more
I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; Hypertensive; Tachycardiac; This is a spontaneous report from a contactable physician (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 22Dec2020 for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) at 112 ug on 22Dec2020 for hypothyroidism. Physician stated, "I was about 2 minutes after the administration of vaccination on 22Dec2020, I have got tingling in both of my arms as well as hard to describe but like a lightness, it's like my arms felt very light. And they observed me and took my vitals and I was definitely hypertensive and tachycardiac". The outcome of the events was unknown. The vaccine was administered at Hospital Facility.
31 2021-01-04 dizziness Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This... Read more
Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot "EJ then it's either I or 1, I don't know then 685", Expiry Date: 31Mar2021) solution for injection intramuscular on 19Dec2020 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Pregnancy status was not reported. Medical history was unknown. Concomitant medication included multivitamins. The patient stated, "I just wanted to know if it's normal or not, I got this first half of the Covid Vaccine on the 19Dec2020 and ever since I have been having like intermittent dizziness (19Dec2020) and it doesn't last very long usually its usually couple of times a day but I just wanted to know if that's normal and if it is how long before it stops?" No treatment was provided for the event intermittent dizziness. The outcome of the event intermittent dizziness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
31 2021-01-04 pain in extremity Solitary enlarged lymph node in left posterior cervical chain, approximately 2 cm in diameter, nonte... Read more
Solitary enlarged lymph node in left posterior cervical chain, approximately 2 cm in diameter, nontender. Enlargement initially felt the morning after receiving the vaccine. The lymph node continued to enlarge for several days and has remained 2 cm (visible bulge) at 7 days post-vaccination. No other cervical or axillary lymphadenopathy. Left arm sore for 24 hours post vaccination. No other swelling, redness, systemic or local reactions.
31 2021-01-04 pain Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3... Read more
Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E4284), via an unspecified route of administration on 22Dec2020 11:30 at a single dose in left arm for COVID-19 immunization. Medical history included asthma, known allergies: dust mites. The patient experienced soreness on day 2 (24Dec2020) and day 3 (25Dec2020), site of injection was swollen, painful, and itched on 24Dec2020. No other vaccine in four weeks received. No treatment received for these events. The patient had no COVID prior vaccination or no COVID tested post vaccination. This is a non-serious report. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
31 2021-01-04 pain in extremity The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtua... Read more
The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtually for my headaches.
31 2021-01-04 pain fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other health... Read more
fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ek5730) intramuscular in the left arm on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 24Dec2020, the patient experienced fever, myalgia, body ache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. After the vaccination, on 26Dec2020, the patient was tested for COVID-19 with a nasal swab which resulted negative. At the time of the report, the outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
31 2021-01-04 dizziness light headed; soreness to site of injection; felt a random itch run along from my hand to up along m... Read more
light headed; soreness to site of injection; felt a random itch run along from my hand to up along my arm; some warmth to the site; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), intramuscularly on 23Dec2020 07:30AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included depression from an unknown date. No allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. At the day of 23Dec2020 at 7:30 am the time of injection patient felt okay. She was let go to go back straight in to work. Once at work she felt light headed for 30 minutes with soreness to site of injection. Patient also felt a random itch run along from her hand to up along her arm. She applied lotion to the site if irritation for some comfort. The next 2 days patient still felt soreness and some warmth to the site. It's unknown if patient received treatment for the other adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The date report was first received from source was 27Dec2020. The events were reported as non-serious. No follow up attempts are possible; information about lot/batch number cannot be obtained.
31 2021-01-04 pain in extremity, pain sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day afte... Read more
sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day after vaccination) chills, low grade temp of 100.4F (went down with Tylenol), malaise, myalgia for one day starting the day after vaccination (Sunday evening and resolved by Monday morning)
31 2021-01-04 numbness whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened al... Read more
whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened also to the soles of feet/hands also became red and itchy; hands also became red; hives; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient (non-pregnant) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 11:45 at single dose at left arm for immunization. Medical history included known allergies: sulfa. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Immediately following vaccination, patient whole left arm was numb, the numbness slightly improved, but then only palms of hands were numb. Later that night, the numbness and itching happened also to the soles of feet, hands also became red and itchy, and then patient got hives that lasted 48 hours, but nightly hives after that, the hives would resolve after taking PO (per oral) diphenhydramine hydrochloride (BENADRYL), and then would come back again that night. Patient was still having them. The adverse events resulted in emergency room/department or urgent care. Outcome of events was reported as recovered/resolved with sequel. The report is considered as non-serious. Information on the lot/batch number has been requested.
31 2021-01-05 pain in extremity 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful.... Read more
8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscular in the right arm on 21Dec2020 15:00 at a single dose for COVID-19 immunization at the age of 31 years old at the workplace clinic. Medical history included asthma and seasonal allergies. Concomitant medications included fluticasone nasal spray, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), salbutamol sulfate (ALBUTEROL), zinc and unspecified multivitamin. On 29Dec2020 16:00, 8 days after the vaccine, the patient had swelling at the injection site on her right arm, it is hot and painful. Also, the patient had pain in right fingers and lymph pain in axillary region. Outcome of the events was unknown. No treatment was given for the events. The events were assessed as non-serious.
31 2021-01-05 tremor, pain in extremity Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable... Read more
Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable other health professional reported for herself. A 31-year-old female patient (not pregnant at time of the report) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), intramuscularly on left arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. Facility type Vaccine was reported as Doctor's office/urgent care. Medical history included SVT, neurocardiogenicy syncope, PVCS, known allergies: PCN. Concomitant medications were not reported. The patient experienced arm soreness, headache, shakiness, nausea, diarrhea on 31Dec2020. No treatment was received for the events. The outcome of the events were not resolved.
31 2021-01-05 feeling of body temperature change, weakness, pain At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate hea... Read more
At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate headache, weakness, sweats
31 2021-01-05 pain, difficulty speaking At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and ha... Read more
At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva. Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness. Vitals were normal. Did not notice any flushing, rash under skin or swelling. The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
31 2021-01-05 dizziness Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is b... Read more
Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as "yesterday", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as "yesterday"), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.
31 2021-01-05 weakness Fever, nausea, muscle pain, weakness
31 2021-01-05 pain I got my first dose of the Pfizer Covid vaccine on Saturday, 01/02/21, around 12:30 pm. About 12 hou... Read more
I got my first dose of the Pfizer Covid vaccine on Saturday, 01/02/21, around 12:30 pm. About 12 hours after I got the vaccine (around 1 am), I woke up with a headache, chills, body aches and a low grade fever. During the night, my temp got up to 99.9 and continued to stay around mid to high 99s throughout the day on Sunday. I tried Tylenol without any success and kept going in and out of chills with body aches and headache persisting. Before I went to sleep Sunday (01/03/21) night, I switched to Ibuprofen and woke up Monday morning without a fever but still experiencing fatigue. Throughout the day on Monday, fever did not return. I stayed home from work on Sunday and Monday. On Tuesday 01/04/20, I was still tired but able to return to work.
31 2021-01-05 pain in extremity Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot ... Read more
Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot in the arm that I recevied the injection on
31 2021-01-05 pain, pain in extremity, tingling headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling ac... Read more
headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling achiness in the arm and wrist; some tingling feeling in the fingertips or feet; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if tingling in feet or fingertips a common adverse effect of the vaccine. The patient experienced headache, body aches, fatigue after receiving the shot. Yesterday at 6PM, she still was feeling achiness in the arm and wrist. She took Ibuprofen and started feeling some tingling feeling in the fingertips or feet. The outcome of the events was unknown. The following information on the lot/batch number has been requested.
31 2021-01-06 pain 12-13 hours post injection experienced low grade fever (100 degrees) chills and body aches
31 2021-01-06 pain Body aches, chills, headache, skin burning. Took Tylenol.
31 2021-01-06 pain in extremity Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache... Read more
Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache, chills Day 3: fatigue, raised area, itching in the arm, pain in arm Day 4: nausea, diarrhea, itching in arm, raised bump at injection site, itchy throat, cough, runny nose
31 2021-01-06 pain in extremity, dizziness Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills N... Read more
Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative
31 2021-01-06 pain EE reports fever of 100.3, achy, muscle and joint pain, and HA. Treatment with Tylenol with no impr... Read more
EE reports fever of 100.3, achy, muscle and joint pain, and HA. Treatment with Tylenol with no improvement. She will continue to monitor.
31 2021-01-06 pain Headache, significantly muscle/body aches, joint pain, significant fatigue. Continual, intermittent ... Read more
Headache, significantly muscle/body aches, joint pain, significant fatigue. Continual, intermittent shooting abdominal pain.
31 2021-01-06 swollen extremities Left axillary swelling developed on day 2 after vaccination. Measuring approximately 6 cm x 6 cm. Si... Read more
Left axillary swelling developed on day 2 after vaccination. Measuring approximately 6 cm x 6 cm. Site is visibly mildly swollen. Feels firm. Tender to palpation.
31 2021-01-06 pain Low back pain Bodyache Injection site pain
31 2021-01-06 pain, pain in extremity Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lo... Read more
Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lower back, shoulder, and hips. Progressed to shooting pains (mild) into both legs and down both arms into fingers and toes. muscle aches and pains persisted until 4pm on 1/7. Also developed inflamed lymph node under left arm pit.
31 2021-01-07 pain in extremity Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by th... Read more
Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by the next morning; however, lower back pain began around 4 pm on 1/3 and gradually worsened, peaking on 1/4 and 1/5. This is still slowly improving. Appears to be some sort of sacroiliac joint inflammation.
31 2021-01-07 migraine, dizziness, tremor, pain First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 1... Read more
First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 Fatigue, malaise, soreness at injection site. 12/31-1/4 Migraines, increased fatigue and malaise, increased lightheadedness, body aches, intermittent dry cough. 1/5-1/8 decreased body aches, decreased fatigue, sustained lightheadedness.
31 2021-01-07 pain in extremity Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injectio... Read more
Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injection area. After 14 hours of the shot, started feeling chill, whole body joint and muscle pain, headache, fatigue, 99.5 fever. on 1/6, took Tylenol every 6 hours, three times in total, 1950 mg total dose. helped. felt a lot better on 1/7, the second day after the shot but still took 2 tablets of Tylenol before went to bed. on 1/8, felt totally fine.
31 2021-01-07 weakness Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday ... Read more
Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday (1/4), worsened over next 2 days. Saw primary doctor on 1/7 who called paramedics to take me to the ER due to EKG results and increased work of breathing. ER doctor suspects mild guillain-barre reaction, I will be following up with cardiology and pulmonology as soon as possible as they were unable to determine exact cause or fix the issues.
31 2021-01-07 migraine, tremor, dizziness, pain I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness an... Read more
I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 fatigue, malaise. 12/31-1/4 Increased fatigue and malaise, migraines, body aches, intermittent dry cough, lightheadedness, photophoibia. 1/5-1/8 Intermittent lightheadedness, slowly improving body aches.
31 2021-01-07 dizziness Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a cont... Read more
Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number EK9231), intramuscular on 29Dec2020 16:30 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications included OTC Vitamins/Supplements. No allergies to medications, food, or other products. The patient experienced lightheadedness x 3-4 hours until after eating a full meal on 29Dec2020 16:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.
31 2021-01-07 tingling, pain in extremity On day 6, developed large, urticarial hives at injection site associated with significant burning, a... Read more
On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; Developed diffuse, pinpoint, non-pruritic, flat rash to trunk.; redness, and itching at injection site; redness, and itching at injection site; Developed mild hives at injection site/large, urticarial hives at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscular from 28Dec2020 08:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cephalosporin and experienced allergies. The patient developed mild hives, redness, and itching at injection site on days 2 and 3. Symptoms resolved entirely on days 4 and 5. On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity. On 30Dec2020, she developed diffuse, pinpoint, non-pruritic, flat rash to trunk. Rash resolved with Benadryl. Extremity pain and burning persists despite Benadryl. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did receive treatment for the events which included Benadryl and Pepcid. The events resulted in emergency room/department or urgent care. The outcome of the events "Developed mild hives at injection site/large, urticarial hives at injection site", "On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity" was unknown; for events "Paraesthesia" and "pain in extremity" was not recovered; and for the other events was recovered on an unspecified date.
31 2021-01-07 tremor, feeling hot, dizziness Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on... Read more
Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on the floor. She stated she felt hot and hadn't eaten all day. She was given a few bites of apple sauce and some Dr. Pepper to drink in case of low blood sugar. She was also given 25mg of diphenhydramine in case of an allergic reaction after the vaccine adminstration at 12:15pm. A few minutes later, she began shaking and stated she thought she was having an anxiety attack. At this time, the patient requested we call 911 because that would make her feel better and so we did.
31 2021-01-07 dizziness Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after pr... Read more
Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after presenting back to vaccine clinic site. Pt received Epinephrine, Solu-medrol, and Benadryl, and is no longer experiencing any sxs.
31 2021-01-07 dizziness Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nau... Read more
Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nausea, and mouth swelling noted. Pt returned to the vaccine clinic and was escorted to the ED. In the ED she was evaluated by the provider, and given epinephrine, solu-medrol, and benadryl, and is now recovered from her reaction and being observed in the ED.
31 2021-01-07 pain R shoulder/upper arm pain that began suddenly, gradually worsened from 7/10 - 10/10. Pain radiated t... Read more
R shoulder/upper arm pain that began suddenly, gradually worsened from 7/10 - 10/10. Pain radiated to middle upper back. Nausea. Anxiety.
31 2021-01-07 pain in extremity STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT AR... Read more
STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT ARM WITH ABDUCTION. LOWER BACK PAIN, MALAISE AND FATIGUE
31 2021-01-07 feeling cold, pain in extremity Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, h... Read more
Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, helping minimally .
31 2021-01-07 dizziness Vax given 12/30/2020 at 2030. Sxs developed later with nausea, vomiting, dizzyness, myalgias, headac... Read more
Vax given 12/30/2020 at 2030. Sxs developed later with nausea, vomiting, dizzyness, myalgias, headache. Presented to ED. IVF, Zofran/diphenhydramine inj, tylenol. Neg COVID-19 test.
31 2021-01-07 dizziness diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness ... Read more
diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital, experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-07 dizziness, pain fever, chills, body aches, extreme fatigue, headache, dizziness
31 2021-01-07 nerve pain hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/p... Read more
hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/pains.
31 2021-01-07 pain in extremity raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my ... Read more
raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination. Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
31 2021-01-07 feeling hot, tingling within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP wen... Read more
within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP went to 166/80 HR 160s. My body began to feel tingly all over even my tongue but it never swelled. I was given 25mg of benedryl and monitored for 30 minutes and finally my body began to normalize and my BP went down to 130/70. I went back to work but when I got home I took more benedryl because my body still had the same tingly feeling. After about 24 hours all symptoms had subsided.
31 2021-01-07 tingling, feeling hot within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body ... Read more
within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body started feeling tingly all over even my tongue, but it never swole. My HR went up to the 160s, my BP was elevated to like 166/80. I was given 25mg benedryl, which calmed the flushed feeling and I was monitored for about 30 minutes and finally my BP and went back down to around 130/70 and my body normalized out besides the tingling which lasted the remainder of the day. I had a little nausea. I went back to work and finished out the day. I took more benedryl when I got home to help with the tingling feeling which finally deminished after about 24 hrs.
31 2021-01-08 dizziness Dizziness, Fever, fatigue, redness and swelling at injection site, Narrative: off work x 1 day;
31 2021-01-08 pain Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, naus... Read more
Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, nausea, enlarged and swollen lymph node under left armpit that is warm to the touch and hurts.
31 2021-01-09 pain, pain in extremity Body aches, chills, joint pain and arm pain. Lasted for 10 hours roughly
31 2021-01-09 migraine Chills, fever of 103, migraine
31 2021-01-09 pain, weakness Extreme fatigue/weakness, headache, chills, dyspnea, chest pain, body aches
31 2021-01-09 pain Fever 102.2F fatigue Chills Body aches Nausea Headache
31 2021-01-09 pain in extremity First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed... Read more
First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed by pain in the shoulder joint when raising arms above head which has persisted for 23 days. Second dose resulted in fever, chills, nausea, swelling of hands and flushing sensation in hands/feet, with maximum fever of 100.2 F documented 24 hours after the second dose. Fever and chills resolved about 36 hours after the injection.
31 2021-01-09 feeling hot, pain, dizziness Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feel... Read more
Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feeling hot, flushed, and tachycardia briefly around 5 min. 10 min developed a pressure in my chest, and dizziness. Within 20 min, developed itching, flushing and hives specifically on left arm, hand, and across chest. Within 45 min, both ears and forehead covered with hives. Hospital staff made me go to ED. Within ED hives continued to progress across the chest and bilateral arms and wrists. Received 50mg of Benadryl, and 40mg of prednisone. Symptoms improved but did not resolved. 3 hrs following vaccine, bilateral lip swelling. Took 40mg of percribed pred and 25mg of Benadryl again around 4pm. Within 12 hrs, significant diarrhea. Hives resurfaced on face, bilateral wrists, arms, and ears around 645 on the 12/29. Fever 100.3 noted on 12/29-12/30. Intermitted hives, and lip swelling remained until 1/1. Nausea diarrhea and body aches until 1/2.
31 2021-01-09 tingling One week after the shot (Left Arm), from my left deltoid to my left hand fingertips have a tingling... Read more
One week after the shot (Left Arm), from my left deltoid to my left hand fingertips have a tingling sensation similar to a limb falling asleep. The frequency ranges from every two hours to every 5 minutes with the sensation lasting for about 5 seconds.
31 2021-01-09 pain, tremor Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart ... Read more
Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart pumping fast. I couldn?t sit due to this so I began pacing the room. I didn?t know this was a side affect so I thought I was over thinking the second dose. I attributed this to all the worry and doubt the media and people around me try pumping in your head. I thought I was having a panic attack. I didn?t alert any of the medical team there because again, I thought I was over thinking it. A few hours later my heart rate had gone down. My Apple Watch helped me monitor this. The next day I felt pain at the injection site, not my normal self, groggy. Slightly feverish and chilled. I work in a cold environment so I couldn?t quite tell if the chilled feeling was a side effect, or the room. Later that evening around 9pm things took a turn. I began running a low grade fever and was shaking from being so cold. About another hour late my fever was up to 101 and I was still shaking from being so cold. I took about 600mg of ibuprofen. I couldn?t sleep, tossed and turned. Probably another hour later my temperature was 102, still shaking uncontrollably. Covered in about 5 blankets I kept waiting it out. And I?d say around 2-3am I could feel my fever breaking. By late morning my temp was back to normal but I felt achy still. Tired, sore. Definitely sore at my injection site. And I don?t know if this is worth mentioning or not but just haven?t been able to shake that panic attack feeling. Like a worry or a dread over me. I just don?t feel as clear-headed as I did before. This is my biggest concern. Just don?t feel myself yet.
31 2021-01-09 pain Woke in middle of night (2am approx. 12hrs post vax) with palpitations, HR 120s, SOB, fever 100.8, s... Read more
Woke in middle of night (2am approx. 12hrs post vax) with palpitations, HR 120s, SOB, fever 100.8, sweats, chills, body/joint aches. Palpitations and SOB persisted for approx 4hrs, off and on. Fever 100.2 and body aches persisted until approx. 5pm the day after 2nd vax (approx 27hrs).
31 2021-01-09 dizziness nausea, feeling flushed, dizzy evaluated by EMTs - VSS and wnl employee continued to feel unwell
31 2021-01-09 pain, tremor vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), ho... Read more
vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), horrible aches and pains, significant fatigue, and persistent headache from about 3am the morning after (on 1/8) and lasting until bedtime that day. The next morning (1/9), most symptoms had resolved except for fatigue. I also experienced a new sx: severe pain and tightness in my chest/torso; was hard to breath normally and could not take a deep breath without experiencing significant pain. This lasted until about 3pm. Fatigue persisted the rest of the day. All symptoms had resolved by the next morning (1/10).
31 2021-01-10 pain, dizziness - Sore shoulder for 2 days - overall body aches (comparable to the flu) for 2 days - malaise (Saturd... Read more
- Sore shoulder for 2 days - overall body aches (comparable to the flu) for 2 days - malaise (Saturday I went to bed at 7pm and woke up at 6am Sunday morning still feeling tired - unusual for me) - light/swimmy headed for 2 days - decrease in appetite for 2 days Worst was on Saturday and Sunday was a little better. Asymptotic by Monday morning
31 2021-01-10 pain, dizziness, weakness 0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before ... Read more
0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before resolving. From 0900 to 1600 experienced fatigue and heaviness that prevented me from working that day. From 1600 to 2000 I felt "normal". At 2100 I went to bed with chills and overall malaise, awoke at 0000 1/8/21 with a fever of 101 F. Throughout the night I experienced severe body aches and a headache that made my teeth and jaw ache 7/10 on the pain scale. Tylenol 500mg taken at 0500 1/8 with relief. Fatigue/weakness experienced until 1700 on 1/8/21 after which I felt like myself again. In total, 2 days of work missed as a result of symptoms.
31 2021-01-10 pain, dizziness 2nd dose: Sore at site of injection left arm 5-6 hrs after injection. 6 AM body aches, chills and di... Read more
2nd dose: Sore at site of injection left arm 5-6 hrs after injection. 6 AM body aches, chills and dizziness, symptoms are resolving at time of reporting 1 dose: only soreness at site of injection few hrs
31 2021-01-10 dizziness, tenderness After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my ... Read more
After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my skin was sensitive to touch. This lasted for about 6 hours. I was also light headed and woozy for about 3 hours. The next morning all of these symptoms were gone.
31 2021-01-10 dizziness Dizziness, light headedness, nausea, chills
31 2021-01-10 dizziness, pain, feeling cold Hot flashes Cold chills Headache Body aches Fatigue Dizziness
31 2021-01-10 tremor, migraine, pain, dizziness I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By ... Read more
I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By 2030 I had severe full body chills and could not stop shaking. I had a severe headache/migraine. Every muscle in my body hurt. This continued on for the entire night. Got tested for COVID the next morning with the rapid results and the symptoms continued with the muscle aches and severe headache. Vision became blurry and I became very dizzy. Slept for 8 hours during the day on 1/7/2021 and then slept another 12 hours that night. The body aches and headaches continued until 1/8/2021 at which the symptoms finally subsided
31 2021-01-10 pain I had tachycardia about 18 hours following my second dose. It lasted a few hours before subsiding. I... Read more
I had tachycardia about 18 hours following my second dose. It lasted a few hours before subsiding. I had this along with aches, headache and fatigue which I expected but the tachycardia was pretty significant. Up and walking to the bathroom HR was in 130s, laying down it was in the 110s.
31 2021-01-10 tingling, numbness, pain in extremity Mild to moderate left arm pain on first couple of days after vaccine, which was not bothersome, foll... Read more
Mild to moderate left arm pain on first couple of days after vaccine, which was not bothersome, followed by constant, numbness and tingling in left hand, started yesterday, has not gone away, and nothing seems to make it better or worse. Does not affect daily functioning currently, has remained the same/not worsened or spread, but is moderately bothersome and uncomfortable. I have never had any symptoms like this before.
31 2021-01-10 pain, pain in extremity Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had linger... Read more
Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had lingering headache. Arm was very very sore and painful. All symptoms disappeared next day.
31 2021-01-10 weakness, numbness, balance disorder The patient developed numbness in her left leg then shortly later numbness in her right arm affectin... Read more
The patient developed numbness in her left leg then shortly later numbness in her right arm affecting her balance and ability to walk accompanied by generalized weakness.
31 2021-01-10 nerve pain Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admi... Read more
Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admitted for observation. Is getting better day to day.
31 2021-01-10 weakness Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of t... Read more
Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of the day. Friday (3 days after) felt tired and weak.
31 2021-01-10 pain body aches chills fever
31 2021-01-10 pain in extremity day 1 fatigue, sore arm day 2 more fatigue, extra sore arm, head ache
31 2021-01-10 weakness, pain, pain in extremity, tingling, numbness it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts ... Read more
it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-11 pain About 6-7 hours after receiving the second Pfizer COVID-19 vaccine, I had the onset of headache, vom... Read more
About 6-7 hours after receiving the second Pfizer COVID-19 vaccine, I had the onset of headache, vomiting, fever to 101, chills, rigors, and diffuse body aches. The symptoms improved with ibuprofen and tylenol. They resolved within 24 hours so about 36 hours post-vaccine.
31 2021-01-11 pain All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body ache... Read more
All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body aches, malaise, severe headache, injection site pain, loss of appetite
31 2021-01-11 numbness, pain, pain in extremity On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thou... Read more
On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thought I was suffering from a stroke. I rushed to my moms and had her to drive me to the hospital where they did a neuro check to include a CT scan which ruled out the stroke but the symptoms lasted about 4 days which came and went with the pain and intensity varying each time which ended around 12/29. I suffered from body aches and night chills one night. Around the 12/29 I began to have pressure around the back of my head which felt as if I was laying on bricks when I laid down. It got to the point to where I couldnt sleep which caused me to go back to the ER on 1/1 where I was given toradol, decadron and sudafed which allowed me to sleep. I was released from the ER with Motrin 800 and contined to take that and Tylenol until the headaches ceased which was about 3 or 4 days later. The headache went away but the pressure still remained. My lymph glands were swollen so I was also given a prescription for amoloxicillin.
31 2021-01-11 dizziness Prolonged tachycardia, light headed
31 2021-01-11 numbness, tingling She received the second dose of the COVID-19 vaccine yesterday. Shortly after that she started to f... Read more
She received the second dose of the COVID-19 vaccine yesterday. Shortly after that she started to feel some strange sensation in her arm. States her arm felt "heavy". She went home and then felt like she had potentially some numbness and tingling up the right side of her face. She did receive the shot in the right deltoid. Patient states she has no weakness in her arms or legs. But they do feel "heavy". Patient states this morning she felt like the tingling sensation on the right side of her face had improved but it felt more swollen than it did yesterday. She states her family members came over this morning and they also felt that she had some swelling to the right side of her face. Patient was administered Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days then follow-up with PCP
31 2021-01-11 tingling, numbness Shortly after receiving 2nd dose she reported feeling strange sensation in her right arm. States he... Read more
Shortly after receiving 2nd dose she reported feeling strange sensation in her right arm. States her arm felt heavy and experienced some numbness and tingling up the right side of her face. On 1/12/21 she woke up and felt tingling on the right side of her face and swelling. She was evaluated in the Emergency Department and treated with Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days.
31 2021-01-11 pain in extremity Sore arm for first day after injection. Resolved about 36 hours after injection.
31 2021-01-11 pain low grade fever x 6 hours severe body aches x 24 hours severe heartburn x 12 hours low grade headach... Read more
low grade fever x 6 hours severe body aches x 24 hours severe heartburn x 12 hours low grade headache x 4 days
31 2021-01-12 pain Chills, fever, headache, body aches,
31 2021-01-12 tingling Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 clie... Read more
Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 client verbalized complaint of tingling sensation to lips and face. Client denied any difficulty breathing. Client administered 50mg of Diphenhydramine via IM to right arm at apx 1546. 1547 BP= 117/70; HR = 98bpm; RR = 18; temp = 97.2. Client verbalized tingling sensation lessening at apx 1550. 1552 BP = 113/69; HR = 92; RR = 15; temp = 97.2 At 16:00 client verbalized tingling sensation had completely subsided. Client denied any difficulty breathing. Client declined transport to ED and instead called friend to pick her up as she was too drowsy to drive per Dr.
31 2021-01-12 pain Fatigue, body ache, chills, nausea, headache. Resolved.
31 2021-01-12 pain Fatigue, fever, chills, body aches, joint pain, skin hurting
31 2021-01-12 lightheadedness, pain Fever,chills, body ache, headache, fatigue, near syncope
31 2021-01-12 pain I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme... Read more
I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme fatigue; sleeping most of the day making it hard to work; feeling worse, not better; fogginess; This is a spontaneous report from a contactable Other-HCP (patient herself). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 04Jan2021 at 08:00 at 0.3 ml single for COVID-19 immunisation. The patient was not pregnant. Vaccine location was left arm. Relevant medical history included depression, anxiety, endometriosis. No known allergies. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), and colecalciferol (VITAMIN D). The patient was vaccinated at Workplace clinic, age at vaccination was 31-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient stated that on 05Jan2021 ''I've felt like I have the flu for the past 3 days-aches/pains, sore throat, sinus pressure, fogginess, extreme fatigue; I'm sleeping most of the day making it hard to work; feeling worse, not better, each day; trying OTC meds- loratadine pseudoephedrine sulfate (CLARITIN D) and chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride (TYLENOL COLD); plan to call doctor if not feeling better by day 5''. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.
31 2021-01-12 pain in extremity Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild ... Read more
Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild chills, fatigue and malaise starting the following morning lasting about 8 hours.
31 2021-01-12 pain in extremity Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm p... Read more
Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm pain. Ibuprofen helped to relieve symptoms. Still feels chills, arm pain, and now fatigue.
31 2021-01-12 dizziness Side effects: headache, joint pain, muscle aches, fever, dizziness, nausea, shortness of breath, fat... Read more
Side effects: headache, joint pain, muscle aches, fever, dizziness, nausea, shortness of breath, fatigue
31 2021-01-12 pain So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fe... Read more
So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fever that was constant from Friday through Sunday. My left leg was twitching and also my left bicep. I had left sided twitching that was off and on. I had fatigue and some aching in my knees.
31 2021-01-12 pain, pain in extremity, feeling cold Sore arm, fever, body aches and chills, sore lymph nodes in armpit of shot arm
31 2021-01-12 pain chills. body aches, low grade fever, fatigue,
31 2021-01-13 pain, feeling hot, feeling cold, dizziness, weakness, tremor 01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Ex... Read more
01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Excedrin and ibuprofen, worked all day and by the end of the shift started feeling worse. Symptoms to include : shaky, felt like she was freezing to death but no fever at this point, skin felt like it was on fire, Around 8:00pm temp of 100PO at this time took 1000mg Tylenol and when she had got the shower skin was very sensitive to the water and felt like it was hot, but the water was not, by 10:00 pm temp of 103, felt shaky, achy all over, dizziness/nausea, muscle weakness, fatigue. Went to bed that night, had night sweats during the night. 01/10/21 got up around 4:30am to get ready for work, continued with severe muscle weakness, shaky, headache, got in shower and fell from being so weak and tired. Gradually through the day got better, had went back to bed that morning and slept almost all day and by 3:00pm -4:00pm was feeling much better.
31 2021-01-13 pain, dizziness Continued Headache, dizziness, swollen lymph nodes, fatigue, chills, body aches
31 2021-01-13 speech disorder Extreme lockjaw unable to barely talk or chew
31 2021-01-13 pain Fever (99.7) body aches, HA, mild diarrhea, fatigue started midnight, symptoms improved with Tylenol... Read more
Fever (99.7) body aches, HA, mild diarrhea, fatigue started midnight, symptoms improved with Tylenol.
31 2021-01-13 pain Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a con... Read more
Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a contactable nurse (patient). A 31-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 07Jan2021 10:30 at single dose in left arm for covid-19 immunization. Medical history included asthma and depression. The patient had no allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included celecoxib (CELEXA) and bupropion. The patient previously received her first dose of bnt162b2 on 18Dec2020 15:00 at the age of 31-years in her left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced moderate injection site pain, moderate body aches, chills and fever 100 on 07Jan2021 22:00. The patient was not received any treatments for the adverse events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
31 2021-01-13 dizziness Mild headache upon waking up, progressively worsening throughout the day, mild lightheadedness, chil... Read more
Mild headache upon waking up, progressively worsening throughout the day, mild lightheadedness, chills, low-grade fever, and brain fog began at approx. 10:00 AM and gradually worsened as day progressed. Symptoms completely resolved as of 8:00 AM 1/10/2021.
31 2021-01-13 pain Nausea, upset stomach body aches and soreness
31 2021-01-13 pain covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; ... Read more
covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; body aches; fever; Headache; This is a spontaneous report from a contactable physician. A 31-year-old female patient (healthcare worker) received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 (9 days before 07Jan2021) for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the COVID vaccine 9 days before 07Jan2021 and got a headache afterward in Dec2020. After 6 days, in Jan2021 the patient had a worse headache, body aches, and fever. She was swabbed for COVID on 06Jan2021 and tested positive. The reporter wanted to know what to do about the 2nd dose. The outcome of events was unknown. A product complaint was filed. information about lot and batch number was requested.
31 2021-01-14 feeling cold, balance disorder, dizziness, pain in extremity 1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting... Read more
1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting 15 min. 1630: Woke up. Felt more tired than usual. 1900: Arrived at work. Felt fatigue and sore arm. 2000: Felt sore arm, fatigue, and mild HA. Drank coffee and this helped with fatigue and HA. 2100: Mild nausea starts. Still have sore arm. Less fatigue, no HA. Still able to eat with the nausea. 2200: Developed chills. I was putting up curtains in an isolation room and had to pause halfway through due to being short of breath as if I'd done something strenuous. I then was short of breath again walking specimens to lab, which is unusual for me. Walking samples to lab involves walking 400 ft and going up and down 1 flight of stairs. 2300: Coworkers keep asking me why I'm always out of breath. They are concerned. Chills are worse now and I go from feeling normal to feeling cold. My hands are like ice and I am gripping my arms to keep warm. I walk 2 samples to lab and each time I am dizzy on the way back. By the 2nd time I have to hold the wall to keep balance. I can no longer hide the side effects and a coworker offers me 650mg Tylenol. I gladly accept. I measure my spO2 and it is 97%. 1/13 0530: I am almost back to normal other than feeling fatigued. 0815: I get home and go to bed. My feet are ice cold so I have to wear socks, but my hands feel normal temperature. I feel like my blanket isn't warm enough. 1330: I wake up and feel absolutely miserable. I am going between having chills to having a hot flash. I can't seem to will myself to leave bed. I'm pretty sure I have a fever, which I haven't had in over 10 years. My mouth is completely dry. 1400: I manage to roll out of bed and take my temperature, which is 101.3F. I feel an overall malaise and keep getting periodic hot flashes, but manage to make it downstairs and I mix 1 liquid IV electrolyte packet w/ 24fl oz. water. I drank the whole thing. I also cooked myself some dumplings and 1 waffle w/ maple syrup due to feeling much hungrier than usual. 1430: I take 1000mg Extra Strength Tylenol after eating. 1830: I feel almost normal except for significant fatigue and go to bed. 1/14 0430: I wake up and feel completely normal. No fatigue. Go about my day as normal. 1545: Suddenly I feel lightheadedness and mild HA. Have trouble with inattention (ex. not following w/ conversation or forgetting what people just said, or listening but not registering, or can't find the words to respond or answers to a question.). I take my Vitals: 117/95, spO2 85%, HR 63. I then try taking a couple deep breaths and spO2 increases to 98% and lightheadedness and HA go away. Then a few minutes later lightheadedness and HA begin again and spO2 is 80-90%. Then I take 2 deep breaths and spO2 is 98% and HA and dizziness improves. This repeats several times and I grow concerned. My hands are cold and the pulse oximeter is $30 from Amazon. However, I used the pulse ox on my mother and she was 97% consistently every time without fail. I also used pulse ox on myself when perfectly healthy and same thing it was 98%+ every time. This is why I was now worried. 1630: I take Tylenol since this seems to have helped with any and every symptom I've had so far and book an Urgent Care appointment. 1700: I get up to take a shower and feel extremely dizzy to the point where I'm worried I might fall. I stumble into the bathroom holding the wall. I take spO2 and it is 87%. 1800: I show up to Urgent Care and after the shower I feel my hands are warm now. At Urgent Care they are using pulse oximeters and I am spO2 99% and HR 64. So they chalk it up to my crappy Amazon pulse ox and they tell me to hang in there. Perhaps if I had not taken a shower before going there it may have been a different story? Hard to say now. Also the Tylenol may have started to work by then. 2200: I am still inattentive, spacey, lightheaded, and fatigued. I then fell asleep on the couch without realizing. 1/15 0230: I wake up and feel fatigued with brain fog, but no more lightheadedness. 0630: I go back to bed because I'm too sleepy.
31 2021-01-14 pain 1/13 got vaccine at 12 noon-about 12 hours later ?Middle of the night woke up with sweats, fever, he... Read more
1/13 got vaccine at 12 noon-about 12 hours later ?Middle of the night woke up with sweats, fever, headache, nausea, body aches, chills, joint pain and rash on right arm. Symptoms continued all through the day and next night. Fever resolved 1/15 in the am with highest fever that day being 99, muscle aches still persisted and headache persisted through the day. This day the headache was the worst symptom and it was very severe. The new thing that started on this second day post vaccination was nausea and abdominal pain which was not present as badly the day after.
31 2021-01-14 pain 4 documented fevers. One fever a week for 4 weeks for approximately 2-3 hours each time. Temperature... Read more
4 documented fevers. One fever a week for 4 weeks for approximately 2-3 hours each time. Temperature max 102.3. went away without medication. Body aches and chills with fever but went away after fever was gone.
31 2021-01-14 dizziness After second vaccine dose on 1/8/2021, I felt fatigue and muscle aches on 1/9/21 in the afternoon. I... Read more
After second vaccine dose on 1/8/2021, I felt fatigue and muscle aches on 1/9/21 in the afternoon. I felt normal on Sunday and throughout the week. Then, 1-14-21 starting around 8am, I developed GI symptoms, stomach cramping, nausea, and also light-headed and muscle aches. I left work and at home developed a headache and fever of 100.8 F which reduced to 100.2 F with ibuprofen. The fever went away over night so I came to work the next day 1/15/21 and continue to have stomach cramping and slight nausea and was concerned about the fever the day before so that is when I called employee health.
31 2021-01-14 pain Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, ... Read more
Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, body aches but improved, sneezing. 12/25-cough, severe nasal and sinus congestion, no smell or taste, sneezing. 12/26-congestion, no smell and improved taste, achy, scratchy throat. Sought medical advise on 12/26 primarily due to congestion and scratchy throat.
31 2021-01-14 tremor, pain Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration o... Read more
Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration (left arm) second dose on 07Jan2021 09:30 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Sulfa drugs and known allergies: latex sensitivity. The patient's concomitant medication included spironolactone, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), and multi vitamin. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation first dose on 17Dec2020, Vaccine location Left arm, lot number EH9899. On 07Jan2021 10:00 PM, the patient experienced Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours. The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not tested positive for covid post vaccination.
31 2021-01-14 nerve pain Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccin... Read more
Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccine in my left arm. Associated with shooting sharp nerve pain radiating down the left arm in the medial nerve distribution, likely from nerve impingement. I am self treating with advil since I am a physician and giving it time to resolve
31 2021-01-14 pain in extremity, tingling, numbness Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout en... Read more
Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout entire arm and under arm; Tingling sharp pain throughout entire arm and under arm; Weakness in arm that injection was placed.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021 at 11:00 AM as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL). The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on unknown date via unknown route of administration for COVID-19 immunization. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 08:00 PM, after the second dose, the patient experienced extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. No treatment was received for the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. The outcome of the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2 dose 1, was not provided and will be requested during follow up.
31 2021-01-14 pain, migraine Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contact... Read more
Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 07Jan2021 09:15 at a single dose on Left arm for COVID-19 immunization. Medical history included Chronic back pain, and latex allergy. Concomitant medication included gabapentin, acetaminophen, tramadol, sulindac, methocarbamol. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 09:30 at a single dose on right arm for COVID-19 immunization. The patient experienced fatigue, body aches, migraine, vomiting, chills, sweats on 07Jan2021 12:30. No treatment received for adverse event. The outcome of the event was recovered on an unspecified date in Jan2021. The events were assessed as non-serious. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
31 2021-01-14 pain in extremity, tingling Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm an... Read more
Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm and woke up about 11 pm with left arm pain, very fatigued. Went back to sleep and woke up around 4 am with fever up to 100.6F, headache, muscle aches, joint pain, and extreme fatigue. My left axilla was swollen with arm pain to mid left chest and back, and my axillary lymph node was painful and swollen to about the size of a large grape. I took 440 mg of Aleve around 8:30 when the fever did not subside. The fever broke and did not return. I slept most of the day and was unable to work. My left axillary lymph node is still palpable as of today, 1/15.
31 2021-01-14 pain I received my second dose of the COVID vaccine on 1/11/2021 at 9:30am. That evening, I developed sev... Read more
I received my second dose of the COVID vaccine on 1/11/2021 at 9:30am. That evening, I developed severe body aches. No fever was ever noted, but I felt hot through most of the next day. The body aches impaired my ability to work on 1/12/2021 and as a result I called out sick. These symptoms resolved the morning of 1/13/2021 and I have felt fine since.
31 2021-01-14 pain Injection site pain appeared right after vaccine administration. Pain became more severe the next da... Read more
Injection site pain appeared right after vaccine administration. Pain became more severe the next day and it lasted for a total of three days(1/8~1/10) The next day of vaccination(1/9), I have symptoms of low grade fever, chills, fatigue, mild body aches, headache, vomiting feeling. However, these symptoms only lasted for one day.
31 2021-01-14 dizziness Pfizer-BioNTech COVID-19 Vaccine EUA Chills/temp 38 (starting 2200 1/10-1/12) Moderate nausea (1/10... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills/temp 38 (starting 2200 1/10-1/12) Moderate nausea (1/10-still present as of 1/15) Mild-mod headache (1/11-1/13) Tachycardia (at rest 105-138 1/10-1/13) Moderate muscle/joint pain - same side as injection from shoulder/collar bone into neck (1/11-still present as of 1/15) Moderate-severe fatigue (1/10-1/14) Dizziness (1/12-1/14) Used ibuprofen and Bengay for soreness w/ mild/fair effect.
31 2021-01-14 numbness, dizziness, tingling, feeling hot Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizzin... Read more
Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizziness, elevated heart rate, chills, tingling in extremeties, burning in throat ; started aprroximately two minutes after administration, took benedryl and water, waited another 15 minutes where signs and symptoms started to subside a little bit and thought I was okay but then came back at about 25 minutes post vaccine where it was decided to go to emergency department.
31 2021-01-15 pain, weakness 1/14 Around 5pm general malaise, headache, chills 1/15 Around 4am worsening headache, body aches, f... Read more
1/14 Around 5pm general malaise, headache, chills 1/15 Around 4am worsening headache, body aches, fever 101.7 Spent all day in bed no energy to get up or do anything 1/16 no fever, general malaise, headache. Got covid test pending results
31 2021-01-15 pain Chills/fever, body aches
31 2021-01-15 pain flu like symptoms, shortness of breath, chest pain with deep inspiration, fatigue, malaise, body ach... Read more
flu like symptoms, shortness of breath, chest pain with deep inspiration, fatigue, malaise, body aches
31 2021-01-15 pain, numbness loss of feeling in left hand, tip of fingers, shooting pain in thumb (comes and goes). immediately a... Read more
loss of feeling in left hand, tip of fingers, shooting pain in thumb (comes and goes). immediately as vaccine was given area where vaccine was given swell up like a hard marble was under skin. about 3 mins after vaccine left hand got cold and all feeling was loss. Arm burned for about 12/16 hrs. feeling has not yet come back in hand
31 2021-01-16 pain 11 hours after injection: fever (100.4), headache, joint pain. 22 hours after injection: fever (103... Read more
11 hours after injection: fever (100.4), headache, joint pain. 22 hours after injection: fever (103.4), severe headache, joint paint, fatigue, body aches Treated with Tylenol and ibuprofen
31 2021-01-16 pain in extremity Itchy skin Nausea Bad Headache Severe L arm pain
31 2021-01-16 pain generalized body aches, shortness of breath, extreme fatigue, headache
31 2021-01-17 pain in extremity Soreness in left arm persisting for 3 days, fever
31 2021-01-17 feeling hot felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest ar... Read more
felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest area; Rash/ rashes in her neck and chest area; swollen lymph node in armpit area; soreness/pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: Mar2021), intramuscular in the left arm on 07Jan2021 at 0.3 mL, single dose for COVID-19 immunization. Medical history included testing positive for COVID in Apr2020. There were no concomitant medications. The patient previously took flu shot and experienced soreness. The patient did not receive any vaccination within 4 weeks prior to the COVID vaccine. The patient called in regards to Pfizer COVID Vaccine. She received her first vaccine last Thursday, 07Jan2021. She was not sure if she can report this as a side effect, but she had some rashes appear just today (11Jan2021), at midnight, in her neck and chest area. The rashes were going away, but she still has some itching. She also stated that she took some over-the-counter diphenhydramine (BENADRYL, UPC: 1254717031, lot number: PJF044, expiration date: Jun2021) tablets to relieve the symptoms. She explained that she started to experience soreness/ pain at the injection site a few hours after receiving the COVID-19 vaccine. The pain in her arm has already went away. She noticed a swollen lymph in her armpit area on Friday morning, 08Jan2021 and it's still a little bit swollen. She didn't expect on getting a rash since she read symptoms only appear around 2-3 days only. Therefore, she is not sure if she can report this as a side effect because its been like 3 days already. She noticed the rash just today, at midnight. She stated that she is still itchy. She stated that there is just a little bit of itchiness in her neck. She felt a little bit warm and itchy in her chest area, at midnight (unspecified date), and she kept scratching. She knows she shouldn't have done that but it was itchy. The patient would consider these events to be non-serious. She did have some soreness with a flu shot before so it's not too serious. She explained she is a healthcare worker. She works in a nursing home facility and they asked if she wanted to receive the Covid-19 vaccine and she filled out the form. She also explained that she doesn't have any allergies to any medications. So, with the rashes that came, she is not really sure what is the cause of it. The events did not require a visit to the emergency room or physician office. She stated she wanted to report this information but she also needs advice on whether she needs to continue taking Benadryl. Her rash is improving, but she is still a little bit itchy. She doesn't have any shortness of breath or anything. It's not a major reaction, just a little bit of a rash/itchiness in her chest and neck area. The outcome of the event vaccination site pain was recovered on 10Jan2021, for lymphadenopathy and rash was recovering, for pruritus was not recovered and for feeling hot was unknown.
31 2021-01-18 tingling Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine howev... Read more
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
31 2021-01-18 pain Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved af... Read more
Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved after 48hrs.
31 2021-01-19 pain 2nd day after the vaccination, my left arm had a swollen bump below the injection site along with pa... Read more
2nd day after the vaccination, my left arm had a swollen bump below the injection site along with pain. I felt fatgued, slight fever, and body aches. I took an antihistamine for 5 days and the symptoms resolved itself.
31 2021-01-19 feeling hot Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become ... Read more
Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become flushed . I gave her oral benadryl 50 mg and 40 mg of famotidine oral. The difficulty in breathing did not lessen. She began to use her accessory muscles. Her O2 sats were 99% via finger pulse oximeter. Breathing became increasingly labored. An Epi pen 0.3 mg was administered. An ambulance was called. Her breathing became less labored, she was transported to the hospital via ambulance to be checked out.
31 2021-01-19 feeling cold, pain BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS F... Read more
BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS FOR ARM AND CHEST.
31 2021-01-19 pain in extremity Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she develope... Read more
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 (Friday, January 15, 2021) she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a deep vein thrombosis of the proximal vein. She also came to the ETC and was ruled out for a PE. The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
31 2021-01-19 pain in extremity Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever wit... Read more
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a thrombosis. She also came to the ETC and was ruled out for a PE The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
31 2021-01-19 migraine, pain, pain in extremity Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started... Read more
Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever. Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.
31 2021-01-19 swollen extremities, pain in extremity Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours... Read more
Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours total. Accompanied by chills, malaise, myalgias. Continues with mild tiredness and shortness of breath on exertion over the next few days. COVID-19 test done on 1/13/2021 due to severity of symptoms, was negative. 3 days later (1/15/2021) left calf pain with mild edema, subsequently diagnosed (1/20/2021) as a left posterior tibialis complete vein occlusion (DVT). Chest CT done to rule out pulmonary emboli. Anticoagulation prescribed (xarelto).
31 2021-01-19 pain HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and... Read more
HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and chest area; 8/10 pain in L axillary and chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly on the left arm, first dose on 17Dec2020 07:15 and second dose on 08Jan2021 07:15, both at a single dose for COVID-19 immunization. There were no medical history nor concomitant medications (within two weeks of vaccination). The patient was not diagnosed with/did not have COVID-19 prior to vaccination, did not receive other vaccines in four weeks prior to vaccination, had no known allergies to medications, food, or other products, and was not pregnant. The most recent COVID-19 vaccine was administered at a hospital facility. On 07Jan2021 18:00, the patient experienced fever 103.5, extreme body aches, headaches 8/10 pain in left axillary and chest area, and HR maintaining 120+ at rest. The patient underwent lab tests and procedures which included COVID test post vaccination with a curative oral swab: negative on 08Jan2021. No treatment was received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
31 2021-01-19 migraine, tremor High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 ... Read more
High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 mark. I?ve been taking Tylenol every 4-6 hours to combat high fever but it wasn?t going down. I had chills with the fever, so bad that my body was shaking. Fever stayed in the 101 range from Monday evening until Wednesday morning. Extreme shoulder pain radiating from left to right on Monday evening - lasted into the early morning on Tuesday. Chest tightness with R shoulder pain Tuesday afternoon from roughly 130p-315p. It subsided and so I did not seek medical attention. I?ve also had a severe migraine the entire time since getting my shot, but haven?t taken my Ubrelvy as I wasn?t sure how my body would react.
31 2021-01-19 pain I have a subjective fever, and fatigue and severe headache and body pain
31 2021-01-19 weakness, balance disorder Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00... Read more
Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00 that night began to have back pain, fever reached up to 102 around 2:00 am and took Tylenol. Felt very weak, headache, difficulty walking and decreased balance. On Jan 5, 2021 still had back ache and headache. On Jan 6, 2021 I felt better and began to have abdominal pain after eating dinner. I assumed it may be because of eating more then I had in past few days and did not attribute to much but the pain gradually increased to a strange burning/pressure across my upper abdomen that night. Very nauseous and ran low grade fever (99.45). Next morning I had less diffuse pain and could localize it to right lower quadrant.
31 2021-01-19 tingling Tingling fingers on side of injection. No pain at site elsewhere in arm. Felt fine on injection.
31 2021-01-19 pain fever, chills, headache, body aches
31 2021-01-21 dizziness Extreme dizziness and headache
31 2021-01-21 weakness, numbness Systemic: numbness in arms, legs, weakness -Severe
31 2021-01-22 vertigo, numbness, dizziness After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to li... Read more
After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to live with it until the 4th day, during working period I suddenly felt dizzy and nauseous, went to throw up, dizziness was intense then I fell off my chair and was rushed to the Emergency for treatment, was treated for vertigo and given Meclizine to reduce the dizziness and nausea. Till date the dizziness wouldn?t go away.
31 2021-01-24 pain 101 fever (w/tylenol), chills, body aches, fatigue, chest tightness and chest pain(only for 1 hour)-... Read more
101 fever (w/tylenol), chills, body aches, fatigue, chest tightness and chest pain(only for 1 hour)--all resolved in 48 hours
31 2021-01-24 feeling hot Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 m... Read more
Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 minutes in to the event. She had premedicated with Benadryl 12.5mg along with Zyrtec. After itching started she was given an additional 12.5 mg of Benadryl. She was monitored for >30 minutes with improvement of symptoms. Rash still present but she said no longer has itching and that she knew her body well and that she was fine to leave. She stated that her mother was in the car waiting for her since she knew that she might have this type of reaction. We had a long discussion about going to the ER but she said she has Benadryl on her if needed and knew when she needed to get to an ER in terms of symptomatology. We also discussed option of having next dose with an allergist. She would like to call her allergist to discuss options but feels comfortable getting 2nd dose knowing how she reacted this time.
31 2021-01-24 dizziness While being observed in waiting area, patient reported that she felt as if she was going to pass out... Read more
While being observed in waiting area, patient reported that she felt as if she was going to pass out. Patient was then lowered to the ground by 2 medics as patient briefly passed out. Patient was taken to medic area where she informed that she often has syncopal episodes.
31 2021-01-24 dizziness While being observed in waiting area, patient reported that she felt as if she was going to pass out... Read more
While being observed in waiting area, patient reported that she felt as if she was going to pass out. Patient was then lowered to the ground by 2 medics in which patient briefly passed out. Patient was taken to medic area where she informed that she ofter has syncopal episodes.
31 2021-01-25 pain in extremity, pain, vertigo, speech disorder Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 ... Read more
Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 minutes. I then felt fine until exactly 3:00 pm (approx. 3 hours following injection). I stood up and immediately felt like passing out. I had excruciating cramping throughout my legs and horrible joint pain in my knees. By 3:30 I had hives covering my right hand- my hand was also very red and swollen and had severe itching/burning. By now I also had horrific joint and muscle pains all over my entire body and the leg cramping was even worse. the hives responded well two doses of Benadryl and the muscle aches somewhat improved with rotation of ibuprofen and Tylenol. By 5:00 am the following day, the joint and muscle pains were worse. My entire body felt like it was on fire and I had excruciating pain in my throat. It was difficult to speak or swallow and I could feel my throat swollen on the inside. My neck was also slightly swollen and the lymph nodes on the left side of my neck were in horrific pain but not swollen. I continued doses of Benadryl, ibuprofen and Tylenol all day and night and slept most of the time. By Sunday Morning, my throat felt even worse and I had 100 degree fever and continued body aches and joint pain. I was seen at a local urgent care who ran various tests (see below) that were negative and advised me to treat as if it were an allergic reaction and go to ER if I got any worse. Fever and pain improved by Monday and by Tuesday I was able to return to work but with significant fatigue and continued pain in my legs. I continued to improve throughout the week. Now the following week I overall feel back to normal other than I have continued leg pain, esp. in my knees by the end of the day.
31 2021-01-25 pain in extremity Swollen lymph node in left armpit for ten (10) hours. Painful to the touch and with arm movement, fe... Read more
Swollen lymph node in left armpit for ten (10) hours. Painful to the touch and with arm movement, felt like a Charlie horse. About the size of a chicken egg. No treatment given. Swelling subsided in late morning. Arm soreness persisted for two more days (through 16 JAN).
31 2021-01-26 pain Fever, chills, fatigue, cough, body aches
31 2021-01-26 pain Nausea, Vomiting, Diarrhea, fatigue, muscle soreness, body aches, headache, small fever
31 2021-01-26 difficulty speaking Within thirty minutes of administration I started feeling itchy around injection site then all over ... Read more
Within thirty minutes of administration I started feeling itchy around injection site then all over my entire body. I stated to have some facial swelling then my throat started to swell/tighten. I was brought to the ED and an IV was started. They administered IV fluids, Benadryl, Prednisone, and Pepcid. The throat swelling started to interfere with my speaking and vocals. They monitored me for 7 hours then I was discharged home. All symptoms returned within a few hours and persisted for a week following. My PCP took over care and prescribed me the following in replace of the medications the ER prescribed: Albuterol HFA, Dexamethasome, Pepcid, Benadryl, Z-Pak, Vitamin D 100,000iu, and Fish Oil. I missed a week of week then was released to work again on 1/25/21.
31 2021-01-26 dizziness one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pr... Read more
one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pregnant female patient received the vaccine; pregnant female patient received the vaccine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional only reported information for the mother (herself). This is the maternal case. A 31-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm, on 11Jan2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient's last menstrual period was 05Dec2020 and the patient was pregnant at the time of vaccination (5 gestation weeks) with a due date of 11Sep2021. Concomitant medications, taken within two weeks of vaccination, included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685) on 21Dec2020 at 09:00 (at the age of 31-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shaking chills, light headed, and one syncopal episode on 12Jan2021 at 01:00. The pregnant female patient received the vaccine on 11Jan2021 at 08:15. The patient did not receive any treatment for the events. The clinical outcome of shaking chills, light headed, and one syncopal episode was recovered in Jan2021 and of pregnant female patient received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the close temporal relationship, the association between the event syncopal episode with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-01-27 unresponsive to stimuli After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medicat... Read more
After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medication administered per EMS EPI given x2 at 0956 and 1015 ASA 325 chewable given at 1004 for c/o crushing chest pain. Emergency response provider arrived present. Pt started with c/o epigastric and then crushing CP. Pt appeared to be unresponsive at 1020 but the several minutes later she is arousable and anxious, breathing labored and she is stating she is "going to die". Transported to ED where delirium was noted and due to elevated ammonia level current presumptive diagnosis is hepatic encephalopathy.
31 2021-01-27 pain in extremity, migraine, pain Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs. Migraine started day... Read more
Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs. Migraine started day after injection, lasted 7 days with mild to moderate relief through use of Advil, Tylenol, fioricet (prescribed by neurologist for migraine). Required Rx of decadrone from neurologist to break migraine cycle
31 2021-01-28 pain, tremor 4pm- tiredness 7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/... Read more
4pm- tiredness 7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/29 @1am- nausea, vomiting, severe chills, shaking, body aches, tiredness. 1/29- bodyaches continue through day.
31 2021-01-28 pain HEADACHE, NECK PAIN, RIGHT SIDED FACE PAIN, BODY ACHES, FEVER
31 2021-01-28 dizziness, lightheadedness Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was ... Read more
Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was given. At 20 mins my throat felt tighter and it was making me cough trying to get air so they gave me 50 ml of benedryl into my right arm. I started to pass out and my breathing was labored so I was given my epipen and taken to the ER. While I was there I was monitored for 4 hours and given 2 more medications. One was a steroid, I?m unsure on the second.
31 2021-01-28 pain in extremity, pain, migraine migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight... Read more
migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight nausea
31 2021-01-28 tingling, numbness numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbne... Read more
numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbness to her left arm; My left knee was buckling, making walking very difficult; My left knee was buckling, making walking very difficult; my right side also became slightly numb, and was also tingling; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO140, expiration date unknown), via an unspecified route of administration in the left arm on 10Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included neuropathy and migraine. The patient did not have COVID prior to vaccination. Patient is not pregnant. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) on unspecified dates for unspecified indications. The patient has not had other vaccines in four weeks. On 10Jan2021, three hours after being vaccinated (at approximately 3:00 PM), the patient experienced complete numbness to her left leg (from her ankle to her hip/waist). Hours later, the patient noted numbness to her left arm. Her left knee was buckling, making walking very difficult. The patient reported to the ER, and after several hours of waiting to be seen by a doctor, her right side also became slightly numb, and was also tingling. 18 hours after symptom onset (at approximately 9:30am, the day following injection), the numbness on her right side resolved. It was also reported that the numbness on her left side did not completely resolve for more than 24 hours. The patient underwent lab tests and procedures which included nasal swab test which was negative on 13Jan2021 . Therapeutic measures were taken as a result of the events which included anti-anxiety medication for calming. The outcome of the events left knee was buckling, making walking very difficult and tingling was recovered on unspecified date, while the rest of the events was recovering at the time of report.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported complete numbness to her left leg (from her ankle to her hip/waist)/numbness to her left arm, left knee was buckling, walking very difficult, right side also became slightly numb and tingling, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
31 2021-02-01 numbness, weakness numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no ... Read more
numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker. The patient had no relevant medical history. There were no concomitant medications. The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital. The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection. She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times. On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up. If someone were to pick it up and let go, she couldn't control it at all. She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb. When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm. She stated that when she touched her neck, it hurt a little, but it was not super significant. She stated that it was debilitating at that point as she was maintaining numbness and "no control of her arm". The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will. She will probably have to go somewhere due to her paralyzed arm, but she had not yet. At the time of the report the event "No control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" had not resolved yet; the event "mild pain at the injection site" resolved on 17Jan2021, the events "Flu like symptoms" and "Threw up a couple times" were recovering and outcome of the events "Numbness has moved up her neck" and "She touches her neck, it hurts a little" was unknown. The reporter assessed the events "Pain injection site" and "Flu like symptoms" as non-serious and assessed the event "Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" as disabling. She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-02-08 one side paralysis, dizziness approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minu... Read more
approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minutes later started c/o headache and neck stiffening, left side weakness. NP said her left pupil was not responding the same as the right one. Benadryl 50mg Im given, EMSA called and client was transported to hospital.
31 2021-02-08 migraine, slurring, speech disorder, tremor black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nause... Read more
black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.
31 2021-02-21 pain 1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweat... Read more
1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweating. Progressed as day went on. Lasted for approximately 3 days. Sore arm, raised welt on arm at injection site. Sore throat, my lymph nodes were swollen. * 1/8 COVID +
31 2021-02-21 numbness Jaw became numb x 5 days. Denies pain of any kind.
31 2021-02-21 dizziness, weakness, pain in extremity blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable ... Read more
blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable to drive home from work.
31 2021-02-21 facial paralysis, dizziness nausea, vomiting, fatigue, HA, dizziness, Bel's Palsy
31 2021-02-22 lightheadedness, dizziness, unresponsive to stimuli Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she reg... Read more
Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she regained adequate mentation without intervention.
31 2021-02-28 pain headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29... Read more
headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29Dec2020; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 29Dec2020 at 13:00 (at the age of 31 years old) as a single dose in the left arm for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date, acid reflux disease from an unknown date, headaches from an unknown date, and irritable bowel syndrome from an unknown date. Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), prenatal vitamins, cetirizine hydrochloride (ZYRTEC), and unspecified allergy shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache on an unspecified date, night sweats on an unspecified date, achy on an unspecified date, chills on an unspecified date, and last menstrual date 19Dec2020 and first administration date of 29Dec2020. The mother was due to deliver on 25Sep2021. The patient did not receive treatment for the events. The outcome of the events headache, night sweats, achy and chills, and exposure during pregnancy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
31 2021-02-28 dizziness, restlessness light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while la... Read more
light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while laying down; weird/ didn't feel normal; get restless; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 20Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included having one thyroid and had a benign tumor removed from behind heart when she was young and birth control. Concomitant medication included benzalkonium chloride, sodium chloride (ALIVE) and desogestrel, ethinylestradiol (ISIBLOOM) for birth control. After taking the shot she got light headed as she was walking to her car on 20Jan2021 15:00. Didn't think nothing of it since she was nervous about taking the shot. Then once she got home, she got really tired. She only had one thyroid so the shot made me really sleepy and she had a few skipped heart beats while laying down. After she slept, she felt fine but weird then after being up for a few hours she would get restless again. She got light headed again the next day going to the grocery store then back restless. She didn't feel normal until this Tuesday, she was not feeling weird and she was not as tired as she had been since she took the shot. She had tried to get seen from her doctor but she was booked up. No treatment was received for the events. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.
31 2021-03-02 pain, dizziness Change in menstrual cycle (period came 5 days early and was substantially lighter); body aches; Head... Read more
Change in menstrual cycle (period came 5 days early and was substantially lighter); body aches; Headache; chills/rigors; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; abdominal cramping; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176, expiry date unknown), via an unspecified route of administration on 08Jan2021 at a single dose as a Covid vaccine. Medical history included allergies to penicillin. Prior to the vaccination, the patient has not had COVID-19. There were no concomitant medications. The patient did not receive other vaccines in four weeks or other medications in two weeks. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2021 at 11:00 AM on the left arm as a Covid vaccine. The patient has not been tested for COVID-19 post vaccination. The patient experienced headache, chills, rigors, body aches, abdominal cramping, lightheadedness, painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later on 08Jan2021 at 11:00 PM. The patient also experienced a change in menstrual cycle (period came 5 days early and was substantially lighter) on an unspecified date in 2021. The patient did not receive treatment for the events. It was reported that the patient recovered from the events with lasting effects.
31 2021-03-20 weakness anaphylactic reaction, difficulty breathing, swollen throat, tight chest, confusion, flushing, weakn... Read more
anaphylactic reaction, difficulty breathing, swollen throat, tight chest, confusion, flushing, weakness, numb tongue.
31 2021-03-22 tremor, pain, tingling Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue;... Read more
Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue; headache; pinched nerve; Achy; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; This is a spontaneous report from a contactable other health professional (other HCP) (patient) reported for herself. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203) via an unspecified route of administration at left arm on 26Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunisation. Medical history included congenital sucrase-isomaltase deficiency (CSID). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) via an unspecified route of administration at right arm on 03Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunization. No known allergies. No other vaccine in four weeks. Other medications in two weeks included topirmirate, levonorgestrel (MIRENA, intrauterine device (IUD)) and low-dose naltrexone (LDN). The patient was not pregnant. Facility type vaccine was at hospital. The patient experienced adverse events included: 12 hours: chills, fever, shaking; 24 hours: achy, fatigue, headache wouldn't go away 6 days: Rash broke out over body (have pictures), pain/tingling and numbness in left arm (injection site). Rash responded to diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC), left arm was still tingling and painful on day 7. Almost felt like pinched nerve. Hand was cold. Pins and needles sensation. The adverse event start date was reported as on 04Mar2021 at 06:30 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not resolved. Treatment received for adverse event included OTC treatment with antihistamines; epinephrine (EPIPEN). No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events rash and chills cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
32 2020-12-31 pain Headache, Fever, Body Aches, Nausea, Chills, Asthenopia, fatigue for 36 hrs
32 2020-12-31 swollen extremities Left axillary swelling/lymphadenopathy
32 2021-01-01 pain in extremity Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was... Read more
Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was so sore and under armpit. Symptoms lasted all day. Next night woke up out of sleep symptoms even worse. Next day same symptoms but now a hard ball that hurts formed near clavicle on side of vaccinated arm. Arm, armpit, clavicle area on right side now all hurt.
32 2021-01-01 pain in extremity Reported at 6:29 sat on toilet with right arm pain of 7-8 out of 10. Reached for her cell phone on s... Read more
Reported at 6:29 sat on toilet with right arm pain of 7-8 out of 10. Reached for her cell phone on sink and had a syncopal episode 1 day post vaccine. reports history of vasovagal and hyperglycemia. A provider she works with was called and she was given juice, crackers, and two Advil. Pain resolved, no other symptoms reported. Is being followed up by her PCP for workup. No other syncopal episodes reported therafeter.
32 2021-01-02 pain in extremity, nerve pain Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as f... Read more
Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as fatigue. Sx worsened on day 5, so I had a virtual visit with a medical provider who prescribed me Valtrex x7d to treat suspected Herpes Zoster, which I previously had in my early 20s.
32 2021-01-02 pain Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches... Read more
Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches, chills, headache and runny nose Symptoms started within 12 hours of receiving.
32 2021-01-03 feeling hot C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagno... Read more
C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagnosed with allergic reaction- minor. Continue to report warmth and heaviness to mid-upper back.
32 2021-01-03 pain in extremity I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine ... Read more
I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine or my Chronic condition. I have called my doctor to follow up. Currently taking Prednisone.
32 2021-01-03 tremor, pain shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in t... Read more
shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in the middle of the night; body aches; as painful as a strep infection; sore throat that was as painful as a strep infection/throat feels sore to the point of Strep/Throat soreness: Felt like sharp razor blades; Feels like she is having an extreme immune response; Feels congestion; severe serum sickness/weird serum sickness; high fever/Had a fever over 101; This is a spontaneous report from a contactable nurse(patient). A 32-year-old female patient received BNT162B2(lot number EH9899) via an unspecified route of administration at Arm Left on 21Dec2020 (from 16:30 to 17:00) at the age of 32 years old at single dose for doesn't want to bring COVID home to her family. The medical history included Migraine headaches. The concomitant medications were not reported. The patient had so many immunizations for international travel, had Yellow Fever vaccine, all of the Guardasil vaccines, had MMR vaccine four times because she never developed immunity to it until the fourth round, got a flu shot yearly,got TDap vaccine every five years because she was an HCP, did Emgality shots( not done it this month. Emgality had a protein inhibitor, was supposed to get Emgality shot on 21Dec2020). On 22Dec2020 the patient experienced severe serum sickness, high fever, body aches to the point that she was shaking uncontrollably, sore throat that was as painful as a strep infection; Caller mentioned she was taking tylenl and benadryl for her symptoms. The patient was a Nurse Midwife. She got the vaccine on Monday evening at 4:30PM. Feeling like she was having a weird serum sickness. Woke up in the middle of the night and she was full of shakes to the point the bed was shaking. She had a fever over 101. Felt like she was having an extreme immune response. She was taking Tylenol and Benadryl around the clock. Woke up this morning and her throat feels sore to the point of Strep. Wondering if she need to distance and get some kind of test. Has been wearing a mask all of the time and doesn't know of anyone people who have COVID that she has been in contact with. Feels congestion and sore throat. Shakes and chills: Began at 02:30. Hard core chills and shakes. High fever over 101: same time as chills and shakes. Woke up from a dead sleep. Didn't have a working thermometer but knows her temperature must have been over 101 by the way she felt. She didn't feel that crappy unless her fever is over 101. She can gauge her own temperature. She experienced throat soreness: Felt like sharp razor blades. The patient was taking numbing throat lozenges. Seriousness: Would say serious. Didn't require hospitalization. She self-treated. Had she not had to work, she would probably have stayed in bed. Has been taking round the clock medicine. The outcome of the events was unknown. The information on the batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported serious events including severe serum sickness, high fever, body aches, shaking uncontrollably, sore throat that was as painful as a strep infection, feels like having an extreme immune response, congestion, chills, woke up from a dead sleep and the administration of the COVID 19 immunization with BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to those, as appropriate.
32 2021-01-04 dizziness, vertigo, pain in extremity 12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lighthe... Read more
12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lightheaded, fatigue, chills, mild nausea, stomach cramping, and muscle weakness all hit pretty hard at once. Notice slight arm soreness as well. Went back inside and essentially collapsed on the couch 5:30pm- Arm soreness is worse. Chills and lightheadedness only mild now. Fatigue has gone down to where I can resume daily activity 12/29 Wake up with moderate sore throat Stabbing arm soreness at injection site Moderate fatigue and nausea persist. Mild chills. Tried to go for a walk outside and found a 30 minute very slow walk extremely tough 12/30-1/2 Moderate sore throat continues. Other symptoms gone 1/1-2 Arm/ injection site soreness slowly fades 1/2: exercise for the day= 70 min yoga and 7.5 miles of walking. Had a couple glasses of wine at dinner (possibly relevant if issues with vaccine are related to high histamine food issues) 1/3 Moderate headache, fatigue, and muscle aches. Skin feels hot. Sore throat worse than the previous days. Mild runny nose. Severe nausea. Go to Urgent care for COVID test and Zofran Rx. COVID rapid test and PCR test both negative. No fever, higher than usual blood pressure 1/4-5 (current) Nausea lower but still moderate, requiring Zofran. Sore throat persists. Mild fatigue and muscle aches. Skin still feels warm. Mild vertigo during exercise
32 2021-01-04 tingling, dizziness Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable ... Read more
Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) Intramuscular on 18Dec2020 at single dose in Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience dizziness. Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Treatment included water, granola bar, and rest. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-01-04 dizziness DEVELOPED DIZZINESS AND NAUSEA SHORTLY AFTER VACCINATION. WAS BROUGHT BY PRIVATE VEHICLE TO EMERGENC... Read more
DEVELOPED DIZZINESS AND NAUSEA SHORTLY AFTER VACCINATION. WAS BROUGHT BY PRIVATE VEHICLE TO EMERGENCY ROOM. SYMPTOMS LASTED ~1 HOUR.
32 2021-01-04 pain Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other hea... Read more
Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on 27Dec2020 08:45 at single dose at right arm for COVID-19 immunization. Medical history reported as none, no Allergies to medications, food, or other products. Concomitant medication was none, the patient did not receive any medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Dec2020 21: 30 (09:30 PM), the patient experienced fever 101.5, body aches, chills, headache. Treatment received for the adverse events included Tylenol. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
32 2021-01-04 pain in extremity Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous repor... Read more
Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.
32 2021-01-04 pain chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp ... Read more
chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.
32 2021-01-04 pain in extremity is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from... Read more
is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported information for both mother and babies. This is the maternal report. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 16Dec2020 11:00 AM at left arm, at single dose for protect as a healthcare provider. Medical history was none. There were no concomitant medications. The patient experienced like arm soreness and slight headache on 16Dec2020, that was pretty much it. Arm soreness started that afternoon on 16Dec2020, she received the vaccine in the morning, at 11am, and maybe like shortly after she noticed, it was there for 1-2 days and went away, and she had since recovered completely. Slight headache started that afternoon on 16Dec2020, and that resolved by the evening, she took Tylenol and it went away. And she was nursing twins, they are about 14 months now. She was aware of the risks of getting it, and the only reason she reported it, is it may be beneficial from a research standpoint, she doubts many lactating mothers, especially twins, are involved. She is personally not concerned, she is probably expecting similar for her second dose, and there is not much research. Her next is dose 06Jan2021. The outcome of the events slight headache was recovered on 16Dec2020, the outcome of the event arm soreness was recovered in Dec2020.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 Same reporter/drug, different patient/event. baby case;US-PFIZER INC-2020518630 Same reporter/drug, different patient/event. bady case
32 2021-01-05 pain Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection heada... Read more
Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection headache. 24 hours post injection chills, aches, malaise, low grade fever. Overall mild discomfort at the injection site.
32 2021-01-05 vertigo Headaches, nausea, chills, vertigo
32 2021-01-05 dizziness Lightheaded, dizzy, nausea, flushed, dry mouth began about 10 min after vaccination
32 2021-01-05 dizziness Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Napr... Read more
Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Naproxen for the headache, and drink water for the dry mouth
32 2021-01-05 dizziness Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light head... Read more
Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light headedness, sweaty palm, hot flashes. She has been drinking water and ate before and after receiving the shot. No reactions to other vaccinations. Has history of anxiety and depression.
32 2021-01-05 pain, feeling cold, tingling, dizziness, pain in extremity Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reactio... Read more
Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reaction to vaccine except for mild soreness and heat around injection site and intense fatigue for three days after. Symptoms went away after the 4th day. Two weeks later on Jan 5th 2021, i began to notice an intense itching, burning, and swelling at the injection site. Pain and soreness in arm made it difficult to do my job and seem to just get worse. Upon the next morning of Jan 6th 2021, pain remained but itching had gone down, but intense burning, soreness and massive redness around injection site remained and seemed to be getting worse. Pain remains and redness has not gone down, arm is very tender near site and lifting and moving arm is very stiff and sore. Feeling of lump or stiffness on injection site comes and goes and feeling of heavy and sore muscles move from upper left arm down to elbow and extend to hand; making movement and function slowed or slightly numb. Stiffness in arm and intense heat at injection site makes it uncomfortable to move or use arm. Cold tingling sensation on occasion and stiffness in elbow joint. Slight dizziness and fatigue follow with pain in arm. Was informed to see a physician on Jan 6th, 2021 who said to fill out vaccination adverse event report and to keep an eye on arm. If pain or symptoms become worse to return.
32 2021-01-05 pain in extremity, tremor Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to ... Read more
Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to 101.8 and uncontrollable shaking/chills, and moderate to severe headache. Rigors lasted about 6 hours, headache persists.
32 2021-01-05 pain fever chills/rigors body aches within 12 of getting vaccine
32 2021-01-05 dizziness, numbness, tingling left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty an... Read more
left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty answering questions, itchy-allergic to benadryl so sent to ER for further evaluation
32 2021-01-06 pain in extremity "My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Oth... Read more
"My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Otherwise I just felt tired, and my skin felt hypersensitive"
32 2021-01-06 numbness, tremor About 5 min after the administration of the second dose of the vaccine I began to experience tachyca... Read more
About 5 min after the administration of the second dose of the vaccine I began to experience tachycardia, difficulty to breath, sweating, numbness in arms and legs and trembling of limbs. I have not history of allergies.
32 2021-01-06 tenderness, dizziness, vertigo As soon as I received my shot it was like an electric shot from the injection shot, up the back of m... Read more
As soon as I received my shot it was like an electric shot from the injection shot, up the back of my neck, into my brain. I was instantly woozy and disoriented. They moved me to observation. My hemiplegic migraine started within 10 minutes of the vaccine. I take a preventative every day, and to be honest after the vaccine it was like I had never, ever taken my preventatives. The migraine I got that day is the worst one I have experienced since the first one I ever got. Now on top of the migraines, the vaccine gave me waves of new symptoms. I was having spells of intense heat flashes, with wooziness, and nausea. So the new symptoms were paired with the hemiplegic migraines that, if you aren?t familiar with, mimic strokes because my whole left side tends to go limp, and I struggle with speech, and cognitive issues. So it really wasn?t all too long before the nurse kindly suggested that I didn?t look great and we should head to the ED. They treated the migraine, gave me a CT, everything came back fine. They reached out to my neurologist, gave me some fluids, really they wanted to keep me a little longer, but I know the migraine drill and just wanted to go home and sleep and eat. I promised to follow up with my neurologist and fill out my CDC form. Over the next week the migraine and extra symptoms seemed to slowly but surely let up. The only note worthy thing was really that my left side would get extra tender at times. Not just my injection site, but it was almost like all my nerve endings all over my left side were on fire at times and a pinch on the thigh may as well have been a stab, or a pat on the back a punch. It was pretty intense at times. And just when I thought it was all over my menses started, you see my hormones trigger my migraines. And once again it was like I wasn?t on a preventative. I had an intense Migraine start. I was able to take my bail out medication (sumatriptan) though and get to work. I moved forward with my day, and just when I thought all was normal, I got one of those brutal heat flashes, the room started moving, and I was nauseous. Unfortunately I was in full PPE, I almost passed out, I had to get a coworker to help, they had to get my supervisor. It was a big, unnecessary-necessary, pride-wounding scene. Now I am not a scientist or a doctor, but I might speculate that people with neurological deficits, like myself, are going to have a harder time with this inactive Covid strand. I would much rather be immune to Covid then catch it though, so whatever I can do to help, and protect myself and family and friends and neighbors, I will absolutely do... But I imagine there is probably an adjustment to be made here for the neurologically impaired. Thanks for your time, and let me know if you have any questions.
32 2021-01-06 pain Fever 101.2 and body aches the day after receiving vaccine.
32 2021-01-06 pain in extremity, pain I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chill... Read more
I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chills fever body aches general malaise lack of appetite, worse than the flu symptoms. I still have some mile symptoms and chills on occasion. The worst of the symptoms is over. I took theraflu and hydrated I only went to the Dr for a note for work
32 2021-01-06 pain in extremity, dizziness Lightheadedness Fatigue Dizziness Sore arm Nausea Malaise
32 2021-01-06 migraine Persist nausea, headaches, migraines, malaise
32 2021-01-06 feeling hot Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert ... Read more
Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert and oriented Narrative: Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. 126/77, P 81, R 18 O2 sat at 96.1% at 1420; @ 1435 106/67, P. 65, R 16, O2 sat 99%; @ 1444 BP 115/63, P 67, R 17, O2 sat 100%.Symptoms resolved ay 1435 and denied any c/o. D/c'd in stable vs.
32 2021-01-06 pain in extremity Sore arm and loose stool 24 hours
32 2021-01-06 dizziness, pain Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body ... Read more
Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body pains/ aches, soreness in all joints and worse on whole left side of body, extremely tired and headache
32 2021-01-07 pain Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, a... Read more
Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, and low grade fever (100.6F oral temp). Symptoms largely resolved within 24 hours; however, had persistent eye soreness (pain with lateral movement) through 72 hours post-vaccination for which additional evaluation was sought.
32 2021-01-07 pain Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days... Read more
Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; This is a spontaneous report from a contactable other HCP (patient). A 32-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration on 28Dec2020 09:45 at single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. Concomitant medication included levothyroxine and topiramate. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced body aches, low grade fever, chills 4 days after vaccine on 01Jan2021 15:30. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 02Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
32 2021-01-07 pain CHILLS, HEADACHE, BODY ACHE, SORE IN VACCINE AREA, NAUSEA, DIARRHEA,COUGH
32 2021-01-07 tenderness Left Underarm soreness and tenderness lasting for 16 days.
32 2021-01-07 numbness Numb face, bilateral arm numbness, difficulty breathing
32 2021-01-07 numbness Numbness to face around nose area.; This is a spontaneous report from a non-contactable nurse (the p... Read more
Numbness to face around nose area.; This is a spontaneous report from a non-contactable nurse (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 30Dec2020 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unspecified date, the patient experienced numbness to face around nose area. The clinical outcome of numbness to face around nose area was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
32 2021-01-07 dizziness ON 1/4/21 AT 4:00PM, DEVELOPED DIZZINESS, CHEST TIGHTNESS, 'HEAVY' ARMS AND LEGS, HEADACHE, HYPERTEN... Read more
ON 1/4/21 AT 4:00PM, DEVELOPED DIZZINESS, CHEST TIGHTNESS, 'HEAVY' ARMS AND LEGS, HEADACHE, HYPERTENSION (DBP>100). WAS GIVEN 25MG DIPHENHYDRAMINE AT 4:25PM. SENT TO ER AT 5PM. REPORTS SHE WAS SENT HOME FROM ER AT 7:30PM WITH A DIAGNOSIS OF DEHYDRATION. PATIENT REPORTS SHE TAKES A NUMBER OF PSYCHOTROPIC DRUGS, INCLUDING VYVANSE, FLUOXETINE, AND WELLBUTRIN. SHE IS CURRENTLY ON A KETO DIET AND TOOK NAPROXEN EARLIER IN THE DAY.
32 2021-01-07 tingling Patient experienced tingling in hands and anxiety after first dose of COVID 19 Vaccine (Pfizer). Pat... Read more
Patient experienced tingling in hands and anxiety after first dose of COVID 19 Vaccine (Pfizer). Patient was monitored for 30 minutes and did not require medical treatment.
32 2021-01-07 tingling, numbness Patient had her COVID injection on 12/29 and she developed numbness/tingling later that night in her... Read more
Patient had her COVID injection on 12/29 and she developed numbness/tingling later that night in her arms, around 9pm (had vaccine at 2pm). She saw provider on 12/31/20 and was given gabapentin to try. She has been taking it twice daily and it helps a little. She said that the numbness seems to be getting less. She said it was all the way from the shoulder to the hands/fingers, now it's just in her hands and fingers. (Both sides, not just injection site). Circulation is good.
32 2021-01-07 pain Pfizer-BioNTech COVID-19 Vaccine EUA At 10pm on January 6th she started having chills and a headache... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA At 10pm on January 6th she started having chills and a headache. She than started with a fever and body aches. Fever 100.5 on 1/7/21 after Tylenol. Symptoms are still persisting. temp was 99.5 this morning 1 hour after taking Tylenol.
32 2021-01-07 pain Pfizer-BioNTech COVID-19 Vaccine EUA on January 6th at 10:00pm individual started having chills. She... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA on January 6th at 10:00pm individual started having chills. She then started having a headache, fever, and body aches. Temp yesterday was above 101 with the use of Tylenol. Today her symptoms are persisting and temp was 99.5 1 hour after Tylenol.
32 2021-01-07 migraine Pfizer-BioNTechCovid-19 vaccine EUA. Headache and migraine lasting approximately 36 hours.
32 2021-01-07 pain, pain Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and ... Read more
Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and body aches, but no fever. She took Advil, which helped but on 1/8 she still has headache and fatigue.
32 2021-01-07 pain Severe chills lasting 4 hours, fever of 101.1, body aches
32 2021-01-07 lethargy Severe lethargy, muscle aches/pains, and fever (101.2F) starting about 12 hours post vaccine. Fever ... Read more
Severe lethargy, muscle aches/pains, and fever (101.2F) starting about 12 hours post vaccine. Fever reached a max of 105.4F at one point but generally held around 102.2F without use of Acetaminophen. Symptoms started subsiding around 36 hours post vaccine.
32 2021-01-07 pain, pain in extremity Sore arm, headache, fever, chills, body aches, fatigue
32 2021-01-07 pain just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias an... Read more
just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; myalgia; fever; Pain in my hips affected my ability to walk/gait; Pain was 8/10, constant, achy and throbbing; This is a spontaneous report from a contactable physician. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685 expiration date unknown), intramuscularly, on an unspecified date in Dec2020 at 17:00 (at the age of 32-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Just shy of twenty-four hours after receiving the vaccine, the patient developed bone/ joint pain in hips and shoulders, myalgias, a fever and pain in her hips which affected her ability to walk/gait. Her pain was 8/10, constant, achy and throbbing. Movement and sitting in the same position exacerbated the symptoms. The patient specified that she did not receive any treatment for the events. She did mention, however, that a hot shower and sleep eased her symptoms. The clinical outcome of bone pain, joint pain, myalgia, fever, pain and difficulty in walking was reported as self-limited and resolved completely within 12-14 hours. It was also reported that since the vaccination the patient had not been tested for COVID-19.
32 2021-01-08 feeling hot, tingling 0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - plac... Read more
0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - placed in supine position, offered oral fluid 0840 continued elevated BP, elevated HR - continued to monitor 0915 continued elevated BP, elevated HR - continued to monitor 0930 reported feeling hot, tingly, sweaty with position change from supine to sitting, BP reduced, HR WNL 0935 transported to ED for continue symptoms > 1 hour post administration
32 2021-01-08 pain 1. Injection site pain: started soon after injection continued to get worse until 1 day after inject... Read more
1. Injection site pain: started soon after injection continued to get worse until 1 day after injection then progressively got better 2. Fever: t-max 38.2 orally noted at 0430 1/6/21. Fevers associated with chills and rigors at times. 3. Extreme joint and body aches: started early morning 1/6/21 and progressively got worse until 1/7/21 then got better with subsiding around 1/8/21. Pain preventing/limiting normal movements such as walking, turning, and weight baring. 4. Extreme fatigue: sleeping for 18-20 hours a day with hard to stay awake 1/6/21-1/8/21. Resolved by 1/9/21.
32 2021-01-08 tingling 1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T ... Read more
1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order. 1403 - Pt reports feeling no change from initial report but does note "some finger tingling". 92% on RA, HR - 88. 1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states "my hands normally feel puffy when this gets worse but they feel normal now". Pt reports upper lip swelling feels "puffy" but unchanged from initial report. 1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA, 25mg of oral benadryl given. 1423 - Pt reports upper lip "puffiness" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment 1428 - Pt reports improvement to feeling of "puffiness", back itchiness remains the same, and pt "feels sleepy" 1438 - Pt reports resolution of upper lip swelling and says "It feels like when I came in", slight back itchiness still present 1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner. Educated patient to call nurse on call number with any further concerns or if symptoms resume.
32 2021-01-08 tingling As soon as it was administered, I felt my heart start racing and felt a tingling sensation through m... Read more
As soon as it was administered, I felt my heart start racing and felt a tingling sensation through my entire body especially in my hands and feet. I let the nurse know under observation and she took my vitals and my BP was high for me as well 146/85. I waited for an hour and then had my husband pick me up. The tingling continued for a week and a half and made it impossible to sleep. It?s slowly gotten better, but I still feel almost a palpitation/flutter feeling.
32 2021-01-08 pain, lethargy, pain in extremity Chills, body aches, lethargy, headache, entire left arm pain
32 2021-01-08 pain General body aches and chills, nausea lasting 72 hours
32 2021-01-08 pain Severe body aches, fatigue, headache, chills, fever.
32 2021-01-08 dizziness, weakness Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into r... Read more
Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into recliner chair and was physically weak. Reclined and provided water and snacks. Patient progressively felt better with 35 min observation, felt "normal" at discharge from clinic.
32 2021-01-08 tingling, numbness, dizziness extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near ... Read more
extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near syncope, body spasms, and left sided chest pain (worse with palpation)
32 2021-01-09 tingling, dizziness, feeling hot, tremor About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my w... Read more
About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my whole body. I was tingly all over. I felt shaky and like I was going to pass out. Very nauseous. My blood pressure was 169/93 @ 0830. The staff had me lay down. About 5 min later I started to feel better. Another 5 min later it happened again in a wave. The symptoms just came over me. My blood pressure @ 0840 was169/104. The staff had me drink water and rest. @0900 the wave came over me again. My BP was 178/111. I drank more water and rested. BP recheck @ 0925 162/112. @940 BP was slowly coming down at 145/109. At that time they transferred me to the Emergency room. My BP came back into normal ranges, and the waves stopped happening around 12pm. I was then released home with plans to follow up with Primary care on 1/11/2021
32 2021-01-09 pain Chills, fever of 102, body aches, and fatigue.
32 2021-01-09 pain Fatigue, body aches, headache, chills.
32 2021-01-09 pain in extremity G2, P1. 21 weeks 2 days at time of vaccination, due 5/19/20. Est fetal weight approx. 15.7ounces as ... Read more
G2, P1. 21 weeks 2 days at time of vaccination, due 5/19/20. Est fetal weight approx. 15.7ounces as of 1/6/20. Mild arm soreness, onset approximately 5 hours after vaccine. Subsided within 36 hours.
32 2021-01-09 pain in extremity chills, entire right arm sore, swollen/painful lymph nodes in right axillary, fatigue, stuffy nose
32 2021-01-10 pain 1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off a... Read more
1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off at work when benadryl and chlortabs started wearing off. As night continued y face is a little swollen, headache, hypersensitive skin, sore tired"
32 2021-01-10 pain 33 weeks gestation. sudden onset of upper abdominal pain, constant with palpable tenderness over b/... Read more
33 weeks gestation. sudden onset of upper abdominal pain, constant with palpable tenderness over b/l CVA, lower abdomen and upper abdomen. urine and labs normal. vitals normal, afebrile. sent to L and D to monitor. good fetal activity and cervix closed. sx gradually decreased and was able to go home but today 1/11 still with diffuse tenderness, worse with activity and some braxton hix contractions.
32 2021-01-10 pain Chill Fever Body ache Flank pain
32 2021-01-10 pain Chills and body aches about 12 hours after vaccine. These symptoms lasted one day. Acetaminophen he... Read more
Chills and body aches about 12 hours after vaccine. These symptoms lasted one day. Acetaminophen helped with symptoms.
32 2021-01-10 pain Felt like I had the flu the day after I received my second dose. Headache, body ache, fatigue, chill... Read more
Felt like I had the flu the day after I received my second dose. Headache, body ache, fatigue, chills, nausea. Last about 12 hours.
32 2021-01-10 pain in extremity Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she h... Read more
Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she had pain and swelling in her right arm. She was seen by a health care provider on 12/31/2020 and an ultrasound showed extensive deep venous thrombosis in the left arm. She was started on a blood thinner (eliquis). She had blood tests done on 1/1/20 and this showed leukocytosis. She was found to have acute myeloid leukemia and admitted to our service for treatment. We do not have blood tests prior to 1/1/20 so it is unclear when her leukemia started. Her deep venous thrombosis could be related to her acute leukemia but I decided to report it due to the proximity to the time of her vaccine. Her arm pain and swelling improved after administration of the blood thinner. She is currently being treated for her leukemia.
32 2021-01-10 pain in extremity Soreness to Left arm lasted for 48 hrs Fatigue started 12 hrs after and lasted for 36 hrs
32 2021-01-10 dizziness Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchi... Read more
Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchiness, generalized joint pain, and body aches, and fatigue. Episode of lightheadedness at around 6pm and near syncope. Started experiencing axillary swelling and pain. All symptoms resoled by 1/9 except for L axillary swelling which persisted until 1/11.
32 2021-01-10 pain fatigue headache fever chills diarrhea vomiting body aches left lymph node is swollen still after th... Read more
fatigue headache fever chills diarrhea vomiting body aches left lymph node is swollen still after three days
32 2021-01-10 weakness fever, chills, headache, and extreme weakness. Some nausea.
32 2021-01-10 pain starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fat... Read more
starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fatigue. Chills and headache resolved after 24 hours. Other symptoms still present 36 hours later. Treated with tylenol.
32 2021-01-11 dizziness 8 min after administration, described a light-headedness and sinus pressure. Also hypertensive. 144/... Read more
8 min after administration, described a light-headedness and sinus pressure. Also hypertensive. 144/91 immediately, then 129/88 2 min later. Symptoms resolved around 5 min later, other than some dizziness when trying to stand. Resolved after 20 minutes.
32 2021-01-11 pain Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have... Read more
Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have a headache. Took Tylenol 1gm, which helped with headache. Approximately at 1:45am on 1/10/21, I started to feel chills body aches, fatigue, abdominal pain, headache, arm pain on the injection site. Took Tylenol 1gm with Benadryl 50mg. Felt my body sweating. Woke up still with chills, and fatigue. Headache was intermittent throughout the day. Took Tylenol 1gm one time at night woke up on 1/11/21 without symptoms except for the arm pain.
32 2021-01-11 dizziness Becoming acutely dizzy, light headed, nausea, head ache, diaphoretic, feeling like about to faint
32 2021-01-11 dizziness, vertigo DIZZY, HEAD FOG, VERTIGO APPROXIMATELY 8 HRS INTO IT
32 2021-01-11 pain Developed fever, chills, aches, fatigue approximately 12 hours post vaccine. unable to report to wo... Read more
Developed fever, chills, aches, fatigue approximately 12 hours post vaccine. unable to report to work the day after vaccine administered
32 2021-01-11 dizziness Dizziness, rash on legs , tiredness
32 2021-01-11 pain Fatigue, muscle ache, body ache
32 2021-01-11 tenderness, pain Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in... Read more
Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in my neck and above clavicle, lymph node is still swollen and tender 4 post injection.
32 2021-01-11 pain HA, body aches, fatigue
32 2021-01-11 pain I started running a fever and body ache after vaccine. On 27th loss taste and smell.
32 2021-01-11 pain Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days),... Read more
Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days), general body aches, fatigue (3+ days).
32 2021-01-11 pain Nausea, headache, itching, body aches.
32 2021-01-11 pain in extremity Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-ye... Read more
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Jan2021 (13:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included abnormal Factor V; and kiwi allergy. Concomitant medication included ibuprofen (ADVIL). The patient previously took Ambroxol, and had drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested since the vaccination. On 06Jan2021 (16:00), the patient had sore arm. The patient did not receive any treatment for the event. The outcome of the event, sore arm, was unknown. Information on batch/lot number was requested.
32 2021-01-11 weakness, speech disorder, dizziness Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusi... Read more
Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
32 2021-01-11 pain Starting two nights after receiving the vaccine writer started to get leg cramps, and burning pain. ... Read more
Starting two nights after receiving the vaccine writer started to get leg cramps, and burning pain. The pain is not similar to flu-like body aches. This continues into the next week and is traveling to abdomen. Writer is unable to obtain medical advice on how to proceed.
32 2021-01-11 vertigo Vertigo, headache, muscle aches, injection site pain.
32 2021-01-11 pain in extremity sore arm, could barely move her arm, fatigue, fever 100.5, vomiting diarrhea
32 2021-01-12 feeling cold, pain 1/11- starting spotting off cycle 1/12 Woke up at 12:30am due to fully body aches, chills and fever... Read more
1/11- starting spotting off cycle 1/12 Woke up at 12:30am due to fully body aches, chills and fever. 7:45am had fever of 102.2 body aches and leg cramps, 2:00pm had fever of 102 and body aches. 10:00pm still had body aches and fever. 10:00am took Tylenol, fever broke to 100.5 still body aches and leg cramps came back.
32 2021-01-12 tingling 30 minutes after vaccine administration patient experienced transient tingling in her left hand. Oth... Read more
30 minutes after vaccine administration patient experienced transient tingling in her left hand. Otherwise patient was stable so patient declined offer of oral diphenhydramine. After checking in with patient an hour after we offered diphenhydramine tingling seemed to have gone away/patient did not report any symptoms.
32 2021-01-12 dizziness, tingling About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began comp... Read more
About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began complaining that she was dizzy and nauseated. Patient was seated on the exam table at this time, and was helped to lay down on the exam table. Vitals were obtained by RN. Patient began complaining of tingling of her lips while vitals were being obtained at 1110. PA was notified and brought to the room to evaluate patient. Patient denied having any difficulty breathing or swallowing, was not experiencing any itching of the mouth, tongue or throat, and did not notice anything else unusual, patient was still dizzy and nauseated. Patient stated that she had a similar reaction to the first dose of the Pfizer COVID vaccine, where the symptoms resolved within about an hour. Nursing staff and PA stayed with patient during the duration of her observation. Patients vitals ranged betwen pulse ox = 98-99%, pulse = 97-106 bpm, B/P = 114-121/80-89 mm hg. Patient also complained of some tingling around the lower jaw at 1147. Patient was observed for 1 hour and 26 minutes after vaccination was received. Symptoms gradually resolved, upon discharge patients lightheadedness had resolved, and the tingling around the lips and jaw were mostly gone. Patient still was not having any shortness of breath, chest pain, trouble breathing, rash or hives, swelling/tingling/numbess of the tongue, mouth, or throat. Discharge instructions were provided by PA, including when to seek further care at the ER or to call 911. Patient felt comfortable driving herself home and left at 1214. About two hours later, pt presented to ED. Pt endorsed throat tingling, lightheaded, nausea. She also stated that while the reaction post Dose 1 and Dose 2 were similar, the reaction after Dose 2 was much more severe. Assessed for transient Bell's Palsy presentation but determined unlikely as no facial asymmetry or deficits were appreciated. RR 24, other vitals WNL. Pt observed for about 1.5 hours before discharging home with instructions to call ED should condition worsen.
32 2021-01-12 feeling cold, pain Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course ... Read more
Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course of the next 3 days, short of breath with minimal exertion, increased heart rate to 150 with minimal movement. Resolved symptoms on 1/10.
32 2021-01-12 pain Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On... Read more
Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On 12/28 my son was tested positive for covid. I tested negative on the 20th and 30th. My symptoms started getting worse (loss of taste and smell) and 01/06 I tested positive. 01/11 at 5PM I had my second dose. I had some body aches and fever (101.5F). chills, sweats and Tylenol and it was not making a difference. Last night around 8PM my temp was to 100.8F and today I woke up and temperature normal and body aches much better.
32 2021-01-12 pain, feeling cold Fatigue, body aches, fever, chills
32 2021-01-12 migraine Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient)... Read more
Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient). A 32-years-old female patient received BNT162B2(Lot number: EK9231) , intramuscular on 06Jan2021 08:15 at 32 years old at Arm Right at single dose for COVID-19 immunization. Medical history included migraine, Allergies to Latex. Concomitant medications included asa, ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (Multi Vit). The patient experienced fever 101, fatigue, nausea, migraine on 06Jan2021 19:00. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 06Jan2021. The outcome of events was recovering.
32 2021-01-12 pain Headache began the next morning and had been returning daily with pain and pressure behind the eyes.... Read more
Headache began the next morning and had been returning daily with pain and pressure behind the eyes. Some sinus inflammation but clear discharge. Swollen lymph node on left side of neck started 1/10 with minor pain.
32 2021-01-12 weakness, feeling cold I work as an occupational therapist in acute care. On 12/28, I was helping a patient transfer from s... Read more
I work as an occupational therapist in acute care. On 12/28, I was helping a patient transfer from supine to sit. She required maximal assistance, and I was briefly in an awkward position with my trunk flexed and rotated towards the right during this transfer. I felt a pull in my left lower back. After this, I iced the area and took 400 mg ibuprofen and this relieved the mild pain I had. The following two days, I made an effort to follow back precautions (avoid bending, lifting, twisting), avoided heavy lifting at work. On 12/29 in the morning, I felt only a mild soreness in my left lower back and was able to go on my workday without issue (avoiding heavy lifting) On 12/29 around 3 pm I received the first dose of the Pfizer COVID vaccine. On 12/30 (day off work) from the time I woke up until around early afternoon I felt a mild weakness and heaviness in both of my legs. It was most notable when I was standing to cook for about 20-30 minutes that my legs felt shaky and I felt the need to sit. I was able to finish cooking without sitting, however, this sensation was abnormal for me as I normally am on my feet for most of the day with an active job without feeling shaky or weak. Around 22:00 on 12/30 I had severe nausea for about an hour or so. I can't fully remember, but several days after 12/28 or 12/29 I started to feel a mild cold sensation in my lower back. I attributed this potentially to my mild back injury, but it was unclear. The sensory change was intermittent and mild, and ongoing until recently. On 1/9 while at work, I started to feel a mild cold sensation below my belly button, in addition to the intermittent lumbar back cold sensation area. On 1/11 at work, the sensory changes to my lower abdomen and back were more apparent after assisting in a maximal assist transfer with a patient. At this time, it was a combination of cold and burning sensations.
32 2021-01-12 dizziness, pain in extremity, pain Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later... Read more
Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later diagnosed as shingles on 01/11/2021 by her PCP. A 01/04/202 COVID test was negative.
32 2021-01-12 tingling, dizziness, numbness, speech disorder Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with ... Read more
Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
32 2021-01-12 pain Patient describes fever and chills and body aches.
32 2021-01-12 pain Throbbing glands on both sides of neck and sublingual, causing tightness in throat and difficulty s... Read more
Throbbing glands on both sides of neck and sublingual, causing tightness in throat and difficulty swallowing beginning about 5 days after injection, continuing into present (10 days after injection)
32 2021-01-12 dizziness Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but ... Read more
Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but full body joint pain/ache and injection site pain/ache.
32 2021-01-12 dizziness, weakness, lightheadedness covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vas... Read more
covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vasovagal symptoms of lightheaded, blurred vision, hearing changes, and weakness of legs while standing. was in healthcare setting working at the time. Initial vitals 87/60, drank apple juice and rested, BP came up 15 min later to 100/75. At approx. 7pm on 12/28/2020 developed chills which turned into sweats with myalgia's and arthralgia's, took 1g Tylenol, at 9pm fever still 101.7*F. Fever lasted approx 8 hours. Nausea resolved. Diarrhea lasted about 36 hours.
32 2021-01-12 tremor, migraine, weakness tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to ri... Read more
tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to right wrist; joint pain and swelling to right wrist; swollen lymph node on right side of body; weakness; skin redness and burning sensation; skin redness and burning sensation; tremors; gum pain; fatigue; migraine; sweating; back pain; first dose of bnt162b2 on 18Dec2020 at 16:00, second dose on 04Jan2021 at 08:00 AM; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELU140), via an unspecified route of administration on 04Jan2021 at 08:00 AM on Right arm at single dose for COVID-19 immunization. The patient medical history included had known allergies with Penicillin, bees and wasp. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol, retinol (VITAMIN A); colecalciferol (VITAMIN D); calcium phosphate dibasic, phytomenadione (VITAMIN K); cyanocobalamin (VITAMIN B12); levothyroxine, liothyronine (NP THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 18Dec2020 at 16:00 on Right arm at single dose for COVID-19 immunization. The patient experienced fever above 101, tachycardia (140 bpm), myalgia, joint pain right arm, joint pain and swelling to right wrist, swollen lymph node on right side of body, weakness, skin redness and burning sensation, tremors, gum pain, migraine, fatigue, sweating and back pain, all on 04Jan2021 at 20:00, events were resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
32 2021-01-13 pain, migraine, dizziness 01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flus... Read more
01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flush feeling, night sweats, body aches, tired, fatigue, lymph node tenderness under both arms and arm at injection site was red and swollen about the size of a baseball. Slept most of the day and still did not feel well when woke up later in the day and called into work evening of 01/09/21. Reports when she woke up the morning of 01/10/21 felt great.
32 2021-01-13 pain Body aches, Headache. Treatment: Ibuprofen, Outcome: Complete resolution of symptoms after taking Ib... Read more
Body aches, Headache. Treatment: Ibuprofen, Outcome: Complete resolution of symptoms after taking Ibuprofen
32 2021-01-13 pain Body aches, Headache; Treatment: Ibuprofen, Outcome: Complete resolution of symptoms
32 2021-01-13 numbness, pain in extremity Chest pain, numbness in face, arm pain, numbness in arm
32 2021-01-13 pain Chills, body aches, headache, and fatigue starting about 12 hours after the vaccine. The chills reso... Read more
Chills, body aches, headache, and fatigue starting about 12 hours after the vaccine. The chills resolved quickly (within 24 hours), but the headache, body aches, and fatigue have continued through today (one week after receiving the vaccine). Ibuprofen has been the only treatment. The symptoms temporarily improve after taking ibuprofen and then return. I have not been able to exercise since receiving the vaccine and I missed one day of work (1/12/21). I have no history of adverse reactions to any other vaccines and I had no adverse reaction to the first dose. I work as a Clinical Nurse Leader on a Critical Care floor. One of my directors suggested I submit a VAERS.
32 2021-01-13 pain Date of symptom onset - ?1/13/21 midday Symptoms - ?EE reports she felt pretty tired of the day aft... Read more
Date of symptom onset - ?1/13/21 midday Symptoms - ?EE reports she felt pretty tired of the day after receiving her 2nd dose of the vaccine. EE reports when she woke up this am she started feeling generalized body aches, chills, ?clammy? and HA. EE reports + congestion and runny nose. EE denies fever but has been taking Tylenol round the clock since yesterday per EE. Last dose of Tylenol taken at 18:30 (1/13) 1000 mg. At time of call temperature 99.6. EE reports her husband called while at work this am and 7- month old son with cough and fever at home. Last day of work and shift - ?currently at work Home remedies? - see ?symptoms? Any improvement? - mild Recommendation? After completing algorithm with EE, EE meets criteria to be taken off of work and to be scheduled for testing. EE educated to notify manager of need to leave work at this time and to contact EH command center for assistance with testing. EE provided with phone number of EH command center. EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE verbalized back understanding and denied further questions at this time.
32 2021-01-13 pain, dizziness Following receiving second dose of COVID-19 vaccine, vaccinated individual had the following reactio... Read more
Following receiving second dose of COVID-19 vaccine, vaccinated individual had the following reactions 12 hours post-dose: chills, body aches, joint aches. The next morning upon waking to get ready for work, she had nausea and was very light-headed and pale, resulting in a missed day at work.
32 2021-01-13 pain Headache, chills, fever, body aches, shivering, fatigue
32 2021-01-13 dizziness, weakness I started feeling weakness, headache and muscle aches on 1/12 the day of 2nd dose of covid vaccine. ... Read more
I started feeling weakness, headache and muscle aches on 1/12 the day of 2nd dose of covid vaccine. On 1/13 I started feeling dizziness, headache and nausea that lasted until now (1/14).
32 2021-01-13 feeling hot, tingling Immediately complained of feeling hot, tingly, anxious, shaky. Noted to have elevated blood pressur... Read more
Immediately complained of feeling hot, tingly, anxious, shaky. Noted to have elevated blood pressure and pulse. Symptoms continued for one hour. Patient was seen in the Emergency Department for monitoring and discharged to home.
32 2021-01-13 tingling Mild tingling on the right side of her mouth and face that started shortly after receiving the vacci... Read more
Mild tingling on the right side of her mouth and face that started shortly after receiving the vaccination. Symptoms were less intense and lasted for a shorter period of time than after the first injection.
32 2021-01-13 dizziness, weakness On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy a... Read more
On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy and I?m having headache and nausea and I still feel those symptoms now.
32 2021-01-13 pain, pain in extremity Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated ... Read more
Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
32 2021-01-13 pain Upon injection I experienced immediate pain throughout the entire vaccine, which I did not experienc... Read more
Upon injection I experienced immediate pain throughout the entire vaccine, which I did not experience with the first dose. I had inflammation around the deltoid muscle and the following day I had pain and soreness that traveled up my trapezius muscle into my neck with some slight neck stiffness and a large lump over my collar bone on that side at the base of my neck. The lump is quite painful to even gentle touch. I also have pain at the site with movement of my left arm, which was the injection site.
32 2021-01-13 pain in extremity, pain body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal... Read more
body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal spotting (not near my expected period dates)
32 2021-01-13 restlessness mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a sp... Read more
mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a spontaneous report from a contactable Physician reporting for herself. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration, in left arm, on 07Jan2021 at 11:15 at single dose for COVID-19 immunisation. Age at vaccination was 32 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) was received via an unspecified route of administration on 21Dec2020 at 09:00 in left arm at single dose. Medical history included major depression, and generalised anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and daily fusion multivitamin. On 08Jan2021 at 01:00 AM the patient experienced injection site soreness, feverish, headache, insomnia, restlessness, mild muscle aches. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.
32 2021-01-13 migraine ~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, napr... Read more
~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, naproxen and Zofran and was able to fall back asleep in about 2 hours.
32 2021-01-14 dizziness, lightheadedness, pain Approx 6 hrs after getting 2nd dose, developed near syncopal episode. Become diaphoretic, heart pal... Read more
Approx 6 hrs after getting 2nd dose, developed near syncopal episode. Become diaphoretic, heart palpitations, light headed, short of breath. Was placed in a room, had tachycardia with heart rate in the 140's, eventually subsided to normal range over the next 4 hrs. Tuesday had flu like symptoms, headache, body aches, chills, fatigue. Then at night had severe headache ontop of head, to even touch which lasted a few moments and subsided leaving generalized headache. Flu like symptoms persisted through Wed.
32 2021-01-14 tingling, dizziness At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and... Read more
At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and light-headed while simultaneously experiencing right-sided tingling, the altered sensation from my forehead to collarbone (right side only). At approximately four hours post-vaccination my right eye had mild blurriness to my vision. The vision resolved within a few hours but the altered right-sided sensations continued for 6 days, gradually improving. The lightheadedness and dizziness that required cool clothes and elevated feet resolved enough to stand after 30 minutes.
32 2021-01-14 dizziness, vertigo Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating a... Read more
Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating and hot flashes over 48 hrs after vaccination. Improvement with Tylenol 1000mg.
32 2021-01-14 pain Developed body aches and headache.
32 2021-01-14 pain, dizziness Dizziness, body ache, fatigue, nausea, swelling/redness around injection site. Resolved.
32 2021-01-14 pain Fever@12am 1/14/21 thru 1/15/21 took tylenol Body aches started @8pm 1/13/21 Chills started @12am 1... Read more
Fever@12am 1/14/21 thru 1/15/21 took tylenol Body aches started @8pm 1/13/21 Chills started @12am 1/14/21 Headache @8pm 1/13/21 thru 1/15/21
32 2021-01-14 pain in extremity Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable ... Read more
Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 08Jan2021 07:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient's historic vaccine included Other Pfizer vaccine on 18Dec2020. The patient experienced hot injection site, sore arm, swollen lip, nausea on 09Jan2021 15:00. Therapeutic measures were taken as a result of events included Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. Information on Lot/ Batch number has been requested.
32 2021-01-14 pain Per patient (trauma nurse practitioner), injection was placed too high and closer to shoulder join... Read more
Per patient (trauma nurse practitioner), injection was placed too high and closer to shoulder joint than in my deltoid. About 3 hours after the vaccine, patient developed intense pain in left shoulder. 24 hours later, patient could not abduct left arm above head without excruciating pain in left shoulder. Three weeks later, patient still experiencing constant mild pain in left shoulder that intensifies with use. She also reports waking up every night from pain in my left shoulder that radiates behind my scapula and down deltoid. Before the vaccine, she never had left shoulder pain.
32 2021-01-14 pain Several days after the first dose, I developed shingles and needed medical attention for this. 12 ho... Read more
Several days after the first dose, I developed shingles and needed medical attention for this. 12 hours after the second dose, I developed fevers, chills, rigors, body aches for 5-6 hours.
32 2021-01-14 dizziness Shortly after receiving Dose 1 of Pfizer-BioNTech COVID-19 vaccine, patient reported feeling dizzy a... Read more
Shortly after receiving Dose 1 of Pfizer-BioNTech COVID-19 vaccine, patient reported feeling dizzy and nauseous. Patient was given water and apple juice. Patient educated on techniques to reduce symptoms/prevent fainting. Patient was then escorted to a room in the facility to lay down and elevate feet. Patient vomited a few times. Patient closely monitored for over 30 minutes by pharmacist and facility staff. Patient symptoms improved and did not require EMS.
32 2021-01-14 weakness Shortness of breath, extreme itching, full body flushing, chest pain, weakness.
32 2021-01-14 feeling cold patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teet... Read more
patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teeth chattering, patient states they feel cold, monitored for 45 minutes, patient left at 1147 states she is ready to go, states I am ok.
32 2021-01-15 pain, migraine Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain ext... Read more
Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain extended into the armpit/lymph area of my left arm and the pain remained steadily severe until Friday 1/15- 3 days after the initial injection. At 1pm on day of shot (1/12/21) had feelings of chills, sweaty and whole body aches. This lasted until Thursday morning 1/14 around 7am. During that time, took Tylenol for the aches and feverish feelings. Arm soreness finally subsided Friday. migraines started Thursday evening into Saturday morning. With little relief from Imitrex (prescription medication for chronic migraines). Went to the emergency room Saturday for a shot of Torodal for the migraine to subside.
32 2021-01-16 tenderness, pain 12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills,... Read more
12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills, body aches, headache. 24 hours after injection, I developed swollen and tender lymph node under my left underarm (the same arm that received the shot). 48 hours after injection, I had horrible night sweats needing to change out of drenched pajamas every 1.5 hours.
32 2021-01-16 pain in extremity, dizziness Burning and itchiness after Injection which went away within an hour. Several hours later I became v... Read more
Burning and itchiness after Injection which went away within an hour. Several hours later I became very disoriented, dizzy, flush, sevwr headache, diahhrea, nauseous (dry heaving), extremely achy in arm , neck and shoulder. Some symptoms are still present 36/hours later.
32 2021-01-17 numbness Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, craw... Read more
Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, crawling feeling to left side intermittently
32 2021-01-17 pain On 1/15 developed Fatigue, headache, fever, chills and body aches. Employee health swabbed her by ... Read more
On 1/15 developed Fatigue, headache, fever, chills and body aches. Employee health swabbed her by PCR and test was Positive for Covid. On 1/16 had no symptoms and was retested by PCR and was Negative.
32 2021-01-18 pain in extremity, pain Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had... Read more
Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had a low-grade fever and I had slight SOB. Not sure if it was due to vaccine or the fact that I'm big and pregnant. The next more I was extremely sore all over. I also experienced major fatigue and a headache. I just rested and felt better afterwards and it went away.
32 2021-01-19 pain in extremity 0710 January 19th I received the second does of the Covid -19 vaccine. The site was very sore all da... Read more
0710 January 19th I received the second does of the Covid -19 vaccine. The site was very sore all day. Around 2230 that night, I started having intermitted sharp pain in my leg arm pit. 0430 January 20th I woke up with sharp pains still in my left arm pit. By 1030 the pain was now constant and extreme. I called my doctor and he told me to come into the office to see him. NP saw me and explained that the lymph nodes in my left arm were swollen. Very tender to touch also. He prescribed me Prednisone twice a day for three days, Ibuprofen, and use hot compresses. So far the pain has gotten better.
32 2021-01-19 dizziness, pain Light headed Fever Body aches Headache Stomach ache Nausea
32 2021-01-19 tremor Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking... Read more
Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking 1000 mg of acetaminophen the shaking resolved in 30 minutes. That same day around 10 AM patient had muscle soreness in neck and shoulders and a mild headache.
32 2021-01-19 pain Temp 100.4F, headache, muscle aches, bony aching, nausea, reduced appetite, fatigue. All resolved af... Read more
Temp 100.4F, headache, muscle aches, bony aching, nausea, reduced appetite, fatigue. All resolved after 1 day except fatigue resolved after 2 days
32 2021-01-19 pain, numbness Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on ... Read more
Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on 1/9 around 1pm. Symptoms lasted for about 8hrs. On 1/10 developed left upper arm, axillary, chest wall, and clavicular soft tissue swelling with significant lymphadenopathy. Lymphadenopathy was tender, multiple nodes ~2cm. Started experiencing severe sharp shooting pain and burning in similar region. On 1/11 started developing weakness in L arm and hand, with numbness in left hand. Went to urgent care on 1/11. Exam demonstrated 4/5 strength of left arm and hand. Started prednisone 40mg on 1/11. Swelling, pain, and weakness persisted. Seen in ER 1/15, exam with persistent weakness and lymphadenopathy. MRI brachial plexus performed which showed multiple enlarged nodes adjacent to brachial plexus. No overt inflammation or compression of brachial plexus. Received IV dexamethasone, and PO prednisone course. Finished 10d of prednisone 40mg with improvement in soft tissue edema, but still with residual weakness and pain. EMG pending. Diagnosed with brachial plexopathy secondary to compressive adenopathy from COVID 19 vaccine.
32 2021-01-19 pain Woke up the next morning with fatigue, body/muscle aches, and headache. Took Tylenol. Symptoms gone ... Read more
Woke up the next morning with fatigue, body/muscle aches, and headache. Took Tylenol. Symptoms gone the following morning. Symptoms started 12-16 hours after dose and lasted 24 hours.
32 2021-01-19 lethargy, pain chills, sweating, severe body aches (comparable to birth contractions), joint pains, lethargy. start... Read more
chills, sweating, severe body aches (comparable to birth contractions), joint pains, lethargy. started at 12:30 am 1/19/21 until 3:00pm that day. Then just the body aches continued with a low grade temp of a 100 until 10:30 pm that night.
32 2021-01-19 pain, dizziness interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; in... Read more
interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; injection site soreness; Chills; fever; This is a spontaneous report from a contactable pharmacist (patient) and a contactable other health professional. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), on 17Dec2020 at 14:30 and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 08Jan2021 at 12:30, each via an unspecified route of administration at right arm at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included bupropion XL at 150 mg. On an unspecified date, the patient experienced 12 hrs. after vaccine administration, chills and subjective fever began and lasted approximately 24 hrs. (until 36 hrs. post-vaccine) severe enough to interrupt sleep throughout the night. Mild body aches during this time, along with lightheadedness, fatigue, slight headache and injection site soreness. The patient didn't receive any treatment. The patient outcome of the events was recovered.
32 2021-01-20 dizziness Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine... Read more
Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine; Intermittent mild Dizziness and nausea 24h after vaccine; Pain at side of puncture, unable to lift arm from 12h to 40 hours after; unable to lift arm from 12h to 40 hours after; This is a spontaneous report from a contactable Physician(patient). A 32-year-old female patient received first dose BNT162B2 (lot number EH9899) , via an unspecified route of administration at Arm Right on 17Dec2020 14:30 at the 32 years old at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medication was levothyroxine. The patient experienced Pain at side of puncture on 18Dec2020 12:00, unable to lift arm from 12h on 18Dec2020 02:30 to 40 hours after on 20Dec2020 06:30, Intermittent mild Dizziness and nausea 24h after vaccine on 18Dec2020 14:30, Mild myalgias 36h after on 19Dec2020 02:30, resolved at 48h post vaccine on 19Dec2020 14:30. There was no treatment received for all the adverse events. There was no other vaccine in four weeks. The outcome of the events was Recovered.
32 2021-01-21 pain in extremity 4 hours after receiving vaccine, I was replacing a door handle, and thought I had moved my arm in su... Read more
4 hours after receiving vaccine, I was replacing a door handle, and thought I had moved my arm in such a way that it had subluxed at the GH joint. The acute, immediate pain in the joint and inability to move my shoulder were surprising. It took me a few minutes to realize this was likely a reaction to the shot. The joint pain migrated to my elbow, wrist, hand, and left side of my neck, and those joints were all cracking for about 2 days. My left shoulder is still experiencing discomfort and cracking frequently when I move that arm.
32 2021-01-21 pain About 12 hours after the dose, I experience severe body aches (especially back and knees), chills an... Read more
About 12 hours after the dose, I experience severe body aches (especially back and knees), chills and nausea. About 24 hours later, the symptoms improved with use of ibuprofen and acetaminophen.
32 2021-01-21 pain DAVELOPED BODY ACHES, FEVER, AND CHILLES THAT LASTED UNTIL 1/21/21 @6AM.
32 2021-01-21 pain FEVER, CHILLS, BODY PAIN
32 2021-01-21 tingling, numbness Immediately following vaccine, I have tingling in my left hand. 20 minutes after vaccine, I started ... Read more
Immediately following vaccine, I have tingling in my left hand. 20 minutes after vaccine, I started to experience tingling in my neck on the left side which then progressed to tingling of the left side of my mouth. 25 minutes after vaccine, the left side of my mouth and my left nare became numb. My left hand still tingled but I lost feeling in my ring and pinky finger on the same hand. All symptoms resolved on their own by 3 hours post vaccine without the need for medical intervention.
32 2021-01-21 tenderness Muscle soreness, severe headache the morning after vaccine about 11 hours after. Joint/muscle aches ... Read more
Muscle soreness, severe headache the morning after vaccine about 11 hours after. Joint/muscle aches began about 5 hours later. Started noticing left a Dillard pain not long after that. Very enlarged left ancillary lymph node noticed around 6pm. Painful with and without touch. Visibly enlarged. Feels about baseball size. Slight enlargement in right axilla but no associated pain or discomfort. Still present next day
32 2021-01-21 dizziness Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-head... Read more
Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-headed", and that her HR was 150. This nurse explained to patient that she needed to sit back down r/t the "light-headedness". Asked patient if she would like some water patient stated "no, she was ok". At 09:56 AM, the nurse noticed "red blotches" to neck of patient. This nurse walked patient to bed in observation room. Denies SOB nor troubled breathing. Benadryl 25mg was given PO @ 09:56 AM. V/S obtained @ 10:02 AM. BP-120/80, P-124, R-18, O2-99. Still voices no s/s of SOB nor troubled breathing. States to this nurse that she had an "anaphylactic reaction" to lobster years ago, in which she did not state this upon receiving the vaccinations. Also has allergies to Zofran and Macrolides. Pt remains in observation @ present time @ 10:06 AM. Redness remains to neck and upper BL arms. Remains in observation @ 10:30 AM. S/S somewhat alleviated, no lightheadness, but does voice nausea. Stated that she only at a "Granola Bar" this morning. HR remains between 97-114. V/S taken @ 10:39 AM BP-118/76, P-98, R-18, 02-99. Remains in observation @ present time. Time is 10:47 AM. S/S of feeling better @ 10:52 AM, remains in observation. Will call an Uber home, will remain in observation until Uber arrives. Denies SOB nor troubled breathing.
32 2021-01-21 pain, pain in extremity Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibupro... Read more
Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibuprofen. Then came intense fatigue and malaise w/body and muscle aches. Lastly, swollen lymph nodes in armpit on arm of injection site and arm pain.
32 2021-01-24 weakness, pain Chills, headache, Fever upto 102.2 degree F, generalized weakness and body ache.
32 2021-01-24 pain Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and... Read more
Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and fatigue.
32 2021-01-24 migraine Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, ... Read more
Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, no headache.
32 2021-01-25 tremor, pain Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe... Read more
Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
32 2021-01-25 pain Fever, body aches, headache, n/v/d
32 2021-01-25 pain Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; T... Read more
Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist (patient). This 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 11Jan2021 17:30 at single dose on the left arm for COVID-19 immunization. The patient's medical history included depression and gastrooesophageal reflux disease (GERD). No known allergies. The patient's concomitant medications included bupropion, famotidine and birth control medication received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number=Ej1685) on 23Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced severe headache, severe body aches, severe joint aches, chills, sweats, fatigue, loss of appetite on 12Jan2021. No treatment received. Outcome of the events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
32 2021-01-25 numbness my face became numb from the nose down; This is a spontaneous report from a contactable consumer (pa... Read more
my face became numb from the nose down; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL3246, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 12:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had allergies: any sulfa medication. The patient was not pregnant. The patient did not have covid prior vaccination. There were no other vaccine/s in four weeks. Other medications in two weeks include: ethinylestradiol, ferrous fumarate, norethisterone acetate (Blisovi 24 FE), citalopram and lamotrigine. On 11Jan2021 12:45, also reported as 'after 20 minutes of receiving the vaccine,' the patient's face became numb from the nose down. Within three hours, the right side of her face had feeling again. Then, another three hours later she began to have feeling in her nose. She went to bed, and the next morning she had complete feeling in the face. No treatment was received for the event. On 01Jun2020, nasal swab: negative. The patient recovered from the event on 12Jan2021.
32 2021-01-26 pain Chills w/ uncontrollable shivering, body aches, exhaustion
32 2021-01-26 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
32 2021-01-26 pain, pain Fever body aches, chills, nausea, headache
32 2021-01-26 pain Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a con... Read more
Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a contactable nurse(patient). A 32-years-old female patient received second dose BNT162B2( lot number Eh9899), Intramuscular at Arm Left on 12Jan2021 11:00 at 32 years old at single dose for COVID-19 immunization. The medical history included Penicillin allergy. The concomitant medication was propranolol. The patient previously took Clindamycin and experienced drug allergy. The Historical Vaccine was first doe BNT162B2 on 23Dec2020 09:00 at 32 years old for COVID-19 immunization. On 12Jan2021 21:30 the patient experienced Fever, chills, body aches, fatigue, headaches, night sweats. All the events resulted in Physician Office Visit. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.
32 2021-01-26 pain Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include heada... Read more
Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include headache, body ache, fever of 101, aches in my bones and fatigue.
32 2021-01-27 pain, feeling of body temperature change hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spont... Read more
hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spontaneous report from a contactable consumer. A 32-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0142, via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a SINGLE DOSE for covid-19 immunization. Medical history included Gluten and dairy allergy. Prior vaccination, patient has had covid-19 from an unknown date to 30Dec2020. Patient was not pregnant during vaccination. Concomitant medications included curcumin, acetylcysteine, ascorbic acid, quercetin, vitamin b complex, vitamin c and colecalciferol. The patient previously took minocycline and zithromax and experienced allergy to both. The patient received the vaccine on 12Jan2021 at 10:30 and started feeling symptoms hot and cold chills, body aches on 13Jan2021 around 1:00 AM. She did not sleep the rest of the night and throughout the day was tired, chills, body aches, nausea. Patient also stated that she started her period the day she received the vaccine which she was not sure if did help her immune system. The outcome of events was recovering. Patient did not received any treatment due to the events. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
32 2021-01-28 migraine, pain 24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest o... Read more
24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest of day. @0500 on 1/28 woke up shivering uncontrollably. Mild fever of 100.5(highest recorded during this whole episode). Body aches, chills, sweats, headache rest of day. 1000 mg Tylenol helped with fever/chills but headache progressed to migraine w/nausea. Took 50 mg sumatriptan and 25 mg doxylamine in evening and this seemed to help with headache and allow me to get to sleep 1/28. Woke up at 0300 1/29 with chills/cold sweats. Took 1000 mg Tylenol again (didn't check temp) and went back to sleep. Woke up at 0530 for work - checked temp since I'm a healthcare worker and it was 100.4 (with tylenol). Waited until clinic opened up and called them at 0700 for recommendations on going to work or not (temp by then was 99.8, with tylenol). Was advised to stay home and if febrile tomorrow to get COVID tested on 1/30. As of right now (1300 on 1/29) headache has returned but mild. Body aches still. Temp 99.4 w/tylenol redosed at 1000.
32 2021-01-28 pain, pain in extremity, feeling hot Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the ni... Read more
Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the night unable to sleep due to side effects. Day after vaccine achy and tired. 2 days after vaccine feel back to normal.
32 2021-01-28 pain Headache, body aches, fatigue, chills, and temp.
32 2021-01-28 dizziness Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes ... Read more
Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes later felt dizziness and light headedness but it only lasted 5 minutes. 20 minutes later pt still has a small bleb at injection site.
32 2021-01-28 seizure Multiple Seizures 24 hrs after event unable to breathe lasted for over one week.
32 2021-01-28 pain Report of body aches, cough, congestion and sore throat. No home remedies. Outcome: referred for te... Read more
Report of body aches, cough, congestion and sore throat. No home remedies. Outcome: referred for testing.
32 2021-01-28 migraine Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks... Read more
Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included spinal stenosis and allergies to cephalosporin. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included gabapentin. On 30Dec2020 19:00, the patient experienced severe headache/migraine which lasted for over 2 weeks, required prescription medication to make them bearable but even then, they didn't go away and were very bad. The patient spent the good part of two weeks in bed or at least not doing her regular level of activity. She went to Urgent Care twice and to the Emergency Room once. The patient was given prescription medication and IV pain medication as treatment for the events. The patient underwent lab tests and procedures which included nasal swab test (COVID-19 virus test) on 11Jan2021: negative result; and the same test on 14Jan2021 with negative result. The patient was recovering from the events. Information on the lot/batch number has been requested.
32 2021-02-01 tingling Date of vaccine - foot, legs, arm, hand tingling. Intermittently since then including today nearly 3... Read more
Date of vaccine - foot, legs, arm, hand tingling. Intermittently since then including today nearly 3 weeks out, most prominent in left arm and hand. Has caused significant anxiety.
32 2021-02-01 pain Tingling around mouth and tongue. Body aches the whole next day.
32 2021-02-02 pain in extremity Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain ... Read more
Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP. A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.
32 2021-02-03 numbness, tingling, feeling hot Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbn... Read more
Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbness and tingling after. For the first 15 mins also had heart palpitations. 12 hours later after waking up face sensation was dull and improved over the night.
32 2021-02-21 pain Injection site pain, body aches, fatigue
32 2021-02-21 seizure, dizziness Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, ca... Read more
Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, came around then eyes rolled back in head, nausea, blood pressure high.
32 2021-02-21 migraine, pain Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took... Read more
Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took ibuprofen at onset of symptoms, headache subsided but the rest lingered for another 24 hours.
32 2021-02-22 vertigo, difficulty speaking 1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop roc... Read more
1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop rocks in mouth. I got extremely nauseous. Within 5 minutes, everything was spinning. Continued progressing. HR 180. Within 10 min, i was in ER. They gave my epi pen but it didn't work right away. They were about to start an epi pen and to knock me out, they gave me Benadryl IV, Pepcid?, and they were 30 seconds from intubating me. My vocal cords; broncho spasms. I slowly started to get better. They monitored me for 7 hours. *Still experiencing, daily, SOB. My voice gets harsh. I run out of breath walking, talking, etc. I use prednisone, 2 inhalers daily; Advere and Rescue inhaler. I also suffer from EXTREME HA since then and am on 2 medications for the HA.
32 2021-02-22 pain in extremity 12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. To... Read more
12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. Took Motrin. Symptoms lasted for 3 days.
32 2021-02-22 pain Body aches, fever, headache
32 2021-02-22 unresponsive to stimuli, tremor PT STATES THAT SHE WAS FEELING WEIRD . PT WAS PALE, STARTED SHAKING AND SAYING THAT SHE WAS GOING TO... Read more
PT STATES THAT SHE WAS FEELING WEIRD . PT WAS PALE, STARTED SHAKING AND SAYING THAT SHE WAS GOING TO PASS OUT. PT SLUMPED IN HER CHAIR, SUPPORTED BY 2 RNS, PT UNABLE TO ANSWER PROMPTS. PT TRANSFERRED TO ED. BEDSIDE VITALS IN OBSERVATIONBP 90/66 HR 79
32 2021-02-22 tingling, numbness The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness ... Read more
The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness to my left arm, left leg, and left side of my mouth and cheek. The left side if where I received my injection. The numbness and tingling resolved after the first day to my arm and leg, but has continues around the left side if my upper lip. The sensation is only intermittent and can last a few hours. No treatments have been tried.
32 2021-02-23 pain in extremity Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monda... Read more
Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.
32 2021-02-23 tingling, pain in extremity My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness acros... Read more
My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness across entire arm, especially at injection site; swollen injection site; tingling across entire arm; soreness across entire arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021 16:00 (lot number: EN5318), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in public health department. The patient's medical history includes sciatic nerve pain, allergic to cats and some dogs, back pain from scoliosis and anemic, all from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient stated her left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after receiving the vaccine in the left arm on 27Jan2021 16:00. Her left hand turned blue like it was cold, but she was not cold anywhere on my body. Her left hand's veins were also mostly purple in the fingertips. The side effect was not painful and lasted about 30 minutes. Other symptoms experienced because of the COVID-19 vaccine in left arm were soreness across entire arm, especially at injection site occurred upon injection and was slowly getting better. The patient took two 200mg of ibuprofen two days (however the patient also reported no treatment was received for the events) after the injection because the pain randomly got worse without any outward cause, swollen injection site occurred upon injection and is the same at this time. Tingling across entire arm occurred upon injection and stopped seven hours later at 11pm. The consumer assessed the events as non-serious. The outcome of the event tingling across entire arm recovered on 27Jan2021 at 11 PM and "my left hand turned blue and the veins in that hand looked very dark (almost purple)" was recovered on 27Jan2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-02-25 pain Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painfu... Read more
Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painful; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 04Feb2021 (10:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). The patient did not have relevant medical history. Concomitant medication included ongoing amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previously took a flu shot a couple of months ago, and had no reaction. On 04Feb2021 (10:00), the pharmacy reportedly screwed up, and gave the patient an entire vial of BNT162B2 instead of one dose. The patient was not feeling any side effects then. In Feb2021, the patient had a giant red circle/rash; and she was really swollen, inflamed and in pain (reported as "painful"). The patient did not receive any treatment for the giant red circle/rash and pain. The outcome of the events was recovering for 'giant red circle/rash', 'really swollen', 'inflamed' and 'pain'; and was unknown for 'gave the patient an entire vial of BNT162B2 instead of one dose'. The reporter had asked about whether she should receive the second dose. Follow-up (08Feb2021): New information received from a contactable consumer (patient) included: reporter information, suspect vaccine details and new events ('giant red circle/rash', 'really swollen', 'inflamed' and 'pain').
32 2021-03-02 speech disorder, dizziness, tingling Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extre... Read more
Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extreme dizziness; tachycardia; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 01Jan2021 at 13:00 (at the age of 32-years-old) as a single dose in the right arm for COVID-19. The patient had no medical history and was not pregnant. The patient did not have COVID-19 prior to vaccination. The patient had no concomitant medications and did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any known allergies. On 01Jan2021 at 14:00, the patient experienced "cloudy," forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness. The patient did not receive any treatment for the events. The clinical outcome of "cloudy," forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
32 2021-03-02 migraine Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare pro... Read more
Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot: EL3247), intramuscular on the left arm (at the age of 32years) on 27Jan2021 at 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraines, kidney stones and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The reported adverse events were fever, migraine, nausea, and throwing up on 31Jan2021 with no treatment received on all events. The patient considered the events as non-serious. Did not results in death, non- life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was unknown.
32 2021-03-03 dizziness Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from... Read more
Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from a Non-contactable Physician (patient). A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 29Jan2021 (at the age of 32-years) at single dose for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. The patient received no concomitant medications. On 29Jan2021 the patient experienced fever, myalgia, chills, rigor, severe headache, fatigue and dizziness. Treatment was received for the events with Ibuprofen and Tylenol. The events had resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
32 2021-03-14 dizziness Swollen throat; headache; dizziness; This is a spontaneous report from a contactable healthcare prof... Read more
Swollen throat; headache; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WL8982, expiry date not reported), via an unspecified route of administration at the left arm on 24Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included food allergy (walnut and pecan allergies). Concomitant medications were not reported. On 24Jan2021, the patient experienced swollen throat, headache and dizziness. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at an urgent care center. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The adverse events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 29Jan2021. Therapeutic measures were taken as a result of dizziness that included an anti dizziness medication. Clinical outcome of the events was not recovered.
32 2021-03-17 pain fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node ... Read more
fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node under her left arm, which is the same side that she received her vaccine; Passed out; Body aches; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283, Expiry Date: Apr2021), via an unspecified route of administration on 27Jan2021 09:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. No family history. The patient previously took first dose of BNT162B2 (Lot# EL1283) on 07Jan2021 for COVID-19 immunization. Vaccination facility type was nursing home patient was employed at; administered by pharmacy. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations received within 4 weeks. No adverse events follow prior vaccinations. Patient had fever: temperature reached 101 degrees, early morning on 28Jan2021; chills on 28Jan2021; body aches: at night of 27Jan2021; passed out: later on day of 27Jan2021, didn't get out of bed, didn't remember passing out. Remembers waking up on the floor; swollen lymph node: under her left armpit/left arm noticed on 28Jan2021, which was the same side that she received her vaccine. Hurts less when she puts her arm down. Really was sore to the point where she had to keep her arm open. She can rest her arm now, but it is still sore. Everything has subsided except for the swollen lymph node. Her energy was back. No relevant tests. Relatedness of bnt162b2 to events for Fever/Chills/Body aches/Passed out/Swollen lymph node in left armpit: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Event relatedness between COVID-19 Vaccine and fever/Body aches/Swollen lymph node in left armpit was Related. Outcome of the event was swollen lymph node was not recovered, outcome of other events was recovering. No investigation assessment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-03-21 dizziness After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness a... Read more
After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness along with nausea, i could not stand and fainted, they carried me to a private area where i was picked up by the ambulance, my vital signs were not ok.
32 2021-03-21 involuntary muscle movements c/o twitching/jerking/clammy skin with minimal responsiveness to commands immediately after vaccine ... Read more
c/o twitching/jerking/clammy skin with minimal responsiveness to commands immediately after vaccine administration
33 2020-12-31 pain I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body ache... Read more
I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body aches mostly on my left side. On 12/25, I started having a strong headache, focused mostly on the left side. On 12/26 the headache continued and I also noticed swollen lymph nodes on both sides of my neck, and behind my ears. Also, it felt like someone had broken my nose and when I would try to bite down or chew I would have a sharp pain and pressure in my nose and sinuses. On 12/27, the headache continued, and I had severe left eye pain, as well as pain chewing and the swollen nodes, that became painful to touch. On 12/28, I went to my PCP and was tested for covid, which was negative. She diagnosed me with a sinus infection and prescribed amoxicillin. On 12/29, I noticed my scalp had lumps on it that were painful and I had a very itchy spot on my forehead, which became swollen as well to about a quarter size lump. I also had other painful spots on my scalp all over and a continued severe headache and left eye pain. I tried to follow up with my PCP on 12/31, but their office was closed, and the on call nurse referred me to urgent care. More painful, swollen lymph nodes have appeared on my face and neck. I wasn't able to be seen at urgent care until today (1/1), and was then diagnosed with Shingles. I was told to continue amoxicillin and to start taking Valtrex. I am very itchy, mostly on my face, scalp, and left side of my body.
33 2021-01-01 dizziness, numbness At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose conscious... Read more
At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose consciousness. I was hypertensive, had cramping in my fingers and felt numbness in my toes. I laid flat on the floor for 30 minutes in observation and began to feel better by 11. The same thing happened 3 more times throughout the day.
33 2021-01-01 pain in extremity Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just a... Read more
Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just around the actual injection site. It has been 9 days and the pain has slowly increased and now aches from the injection site, my entire bicep muscle, and just below my elbow
33 2021-01-01 dizziness Shortness of breath, elevated heart rate, elevated blood pressure, dizzy, diaphoresis. Still had ep... Read more
Shortness of breath, elevated heart rate, elevated blood pressure, dizzy, diaphoresis. Still had episodes of tachycardia and diaphoresis at 8pm. Following day headache and fatigue.
33 2021-01-03 difficulty speaking, feeling hot 15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash ... Read more
15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl. I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week. After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching
33 2021-01-03 weakness General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Ras... Read more
General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Rash on chest/neck; This is a spontaneous report from a contactable Pharmacist. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscularly on 22Dec2020 13:15 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced rash on chest/neck. General weakness requiring assistance to stand on 22Dec2020 17:00 with outcome of recovered in Dec2020. The date report was first received from source was 23Dec2020. Patient received Fluid bolus, IV benadryl, IV steroid as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The events were reported as non-serious.; Sender's Comments: The reported events rash on chest/neck and general weakness requiring assistance to stand were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-03 feeling hot Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches ... Read more
Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches on face. Took vitals. Administered Benadryl. Monitored for 1.5 hours. Still itchy. Went home, took more Benadryl. Itchiness subsided by the following day.
33 2021-01-03 swollen extremities by 3pm the next day after vaccine injection, my underarm started to hurt- by that night it started t... Read more
by 3pm the next day after vaccine injection, my underarm started to hurt- by that night it started to swell and the pain continually got worse. I went to urgent care where I saw APRN who told me my lymph node had swollen as my lymph nodes were working at fighting off the vaccine.. swelling went down by Wednesday, 12/23/20 and pain gone by 12/25/20.
33 2021-01-03 pain in extremity mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from ... Read more
mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
33 2021-01-04 feeling hot, dizziness 25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and i... Read more
25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and itchy. II was taken to the Emergency Department for further observation. I I also experience some nausea, my tongue was slightly itchy, I had a stomach ache and some redness/swelling round the injection site. At the ED I was given 25 md Benadryl PO and observed for another hour and a half before being discharged.
33 2021-01-04 tingling, pain, numbness Immediate onset of numbness and tingling in 4th and 5th digits, left hand. Followed by a burning pa... Read more
Immediate onset of numbness and tingling in 4th and 5th digits, left hand. Followed by a burning pain Seen via telehealth 12/30/20 Recommended conservative measures Started on NSAIDs Examined 1/4/21 Script for PT provided
33 2021-01-04 pain in extremity Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole ... Read more
Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it. woke up once in middle of night at 4am with racing heart but went back to sleep. Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs. having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath. Temps of 99.5 most of morning. started taking tylenol total of 1 gram. 1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s). O2 sat remained normal. Went to ER for testing for covid in case this was covid--test negative. Felt a little better morning of 1/4--no fever. tried to work 1/2 day; called out sick. lots of brain fog, fatigue mental slowing. still having intermittent chest tightness and sob; feel like i cannot expand my lungs. deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved. i'm a physician, i'm concerned this was a severe reaction and was advised to report this.
33 2021-01-04 pain in extremity really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was... Read more
really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was anxious.; almost felt like her blood pressure was up.; Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EIC9231), via an unspecified route of administration on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient was calling to report that she got the COVID vaccine yesterday, and she wanted to put input in on the effects she experienced last night. She is a pharmacy transition specialist. She doesn't have a prescribing doctor. A few hours after, she was really tired. She could have fallen asleep at her desk. Then, last night, her heart was like pounding but not beating fast if that makes since. Her heart rate wasn't up that much, but it felt like it was going to come out of her chest. She couldn't sleep because of it. She had a headache. She received the vaccine at 11:30. She is not as tired today. Yesterday, she could have just laid head back and went to sleep. The rest of the side effects started right after dinner. She couldn't sleep because she was anxious. Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm. It almost felt like her blood pressure was up. This happened right around after dinner. The headache is hanging over into today. It could be still there because she didn't sleep. Her arm is sore still. It isn't serious. The handwriting was bad on her card so it was hard for her to read the lot number. The outcome of the event Headache, sore arm was not resolved, the outcome of the event really tired was resolving, the outcome of the event heart pounding was resolved in Dec2020, while the outcome of the other events was unknown.
33 2021-01-04 dizziness tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residu... Read more
tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
33 2021-01-05 nerve pain, dizziness 103 fever, chills, severe muscle pain, hypersensitive nerves, chest pain, headache, lightheaded
33 2021-01-05 dizziness About 12 hours after I received the second dose of the covid vaccine, I started to get severe chills... Read more
About 12 hours after I received the second dose of the covid vaccine, I started to get severe chills and headache followed by fever that lasted all night and was up to 101.4 F. The fever improved this morning around 9 am, however I continued to have headache, myalgia, and fatigue all day. I also have intermittent nausea and difficulty standing or walking around because of feeling like I will pass out. I feel slightly improved tonight but still not normal. I called the employee health this morning to inform them.
33 2021-01-05 pain in extremity Arm was sore for 48 hours post injection. Ibuprofen was used for treatment
33 2021-01-05 pain Body aches, fever over 100.4, joint pain, chills
33 2021-01-05 dizziness DIZZINESS
33 2021-01-05 dizziness Last night (4 hours after injection) axillary lymphnodes on injection side were enlarged and severel... Read more
Last night (4 hours after injection) axillary lymphnodes on injection side were enlarged and severely painful. Upon waking this morning axillary lymphnode pain persists, left inguinal lymphnode is painful, moderate to severe fatigue and temperature of 99.9 degrees when checked at work with mild dizziness. Heart palpitations while trying to sleep last night, resting heart rate was 86 BPM higher at times.
33 2021-01-05 pain in extremity Left arm pain and headaches and tiredness
33 2021-01-06 tingling, numbness 1420: Vaccine administered. 1425: Reported right arm numbness distal from injection site. Circulatio... Read more
1420: Vaccine administered. 1425: Reported right arm numbness distal from injection site. Circulation intact. ROM intact. 1452: Complains right arm numbness, right hand cooler to touch than left. 1500: Complains of right arm numbness- temp 97.0 Resp 16 HR- 67 BP- 130/85 1515: Reports somewhat improvement of numbness. Temp- 97.2 Pulse- 78 Resp- 16 BP- 124/86 1530: Reports somewhat improvement of numbness. Temp- 97.5 Pulse- 70 Resp- 18 BP- 114/79 1545: Reports right arm still tingling no more or less than previously reported. Temp- 97.1 Pulse- 74 Resp- 17 BP- 116/79
33 2021-01-06 pain About 12 hours after receiving the shot, I woke up with chills, body aches, and nausea. Fever peaked... Read more
About 12 hours after receiving the shot, I woke up with chills, body aches, and nausea. Fever peaked at 100.4. Could not sleep for 4 hours, probably related to the fever. Took 400mg of motrin after 2 hours of fever, temperature was normal by 10 am.
33 2021-01-06 pain After 6-10 minutes of the injection , I started having shooting pain from the injection site, throug... Read more
After 6-10 minutes of the injection , I started having shooting pain from the injection site, through my left clavicle area to around the back of my neck. After 15 minutes those muscles described started tensing and my muscles in the back of my neck tightened to the point I can?t look left to right (turning motion). It?s now Almost 3 hours after and symptoms remain same.
33 2021-01-06 dizziness Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-y... Read more
Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 28Dec2020 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 28Dec2020 at 08:00, the patient experienced dizziness and nausea. No therapeutic measures were taken as a result of the events. The events resulted in the patient requiring a doctor/clinic visit. The clinical outcome of dizziness and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
33 2021-01-06 pain in extremity I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/2... Read more
I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/21 & 12/22 I was SUPER tired in the afternoon/evening. Seems better 12/23. Felt totally fine otherwise, but definitely had significant fatigue that is not normal for me at all. I still plan to get the 2nd dose as scheduled.
33 2021-01-06 pain in extremity Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes... Read more
Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes/chills alernating
33 2021-01-06 dizziness Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and ... Read more
Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and after the injection she felt all the blood rush down her arm and she stated the injection site came out a bit and had a little bump. She went to the observation area and was feeling faint and light headed. She was taken to a separate room and she became a little faint and was given some water and kept longer for observation. After about an hour shes feeling much better and her color as returned and only feeling slightly light-headed.
33 2021-01-06 pain Severe Achyness Fever 100.2 Headache Stomach ache
33 2021-01-06 feeling cold SkinRash COLD SENSATION RADIATES DOWN LEFT ARM Narrative:
33 2021-01-06 pain Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, B... Read more
Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, Body aches, headache, severe pain in arm of injection. 04:00 AM: Fever 101 F 08:00 AM: Fever 100.4 F. Tylenol taken. Headache and body aches throughout the day. 1/6/2021: headache and body aches most of the day ALL Symptoms gone by 48 hours post vaccine
33 2021-01-07 feeling hot 4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathi... Read more
4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathing trouble. 5: 03 pm pt was evaluated by EMS BP 162/105, P91, O2 sat 100%, EKG done 5: 09 pm BP 136/84 P 86, O sat 100 %. Pt reports reports feeling better, declined transport to ED. Pt left AMA.
33 2021-01-07 lightheadedness Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home... Read more
Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; This is spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284), intramuscular at the right arm on 29Dec2020 07:15 at a single dose for COVID-19 immunization. Medical history included depression. No known allergies. The patient is not pregnant. No COVID prior vaccination. Facility type (vaccine) was hospital. No other vaccine in four weeks. Concomitant medications (in two weeks) bupropion hydrochloride (WELLBUTRIN XL), vitamin B complex, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), ergocalciferol (VIT D), zinc and L-lysine. On, 29Dec2020 at 08:00, approximately 45 minutes after receiving vaccine she felt like she was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. The patient drank juice on way to emergency department and started feeling better about 1 hour later. The events resulted in emergency room/department or urgent care. No treatment for the events. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on unspecified date.
33 2021-01-07 pain in extremity Arm soreness, flu like symptoms, chills, sinus pain, overall sick feeling.
33 2021-01-07 dizziness, tremor Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of ... Read more
Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.
33 2021-01-07 pain Deltoid ache which has since resolved. Ache in Shoulder/axillary joint, has continued through today ... Read more
Deltoid ache which has since resolved. Ache in Shoulder/axillary joint, has continued through today (3 weeks since the Vaccine dose). Hurts when I left my arm above shoulder height
33 2021-01-07 tingling Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth
33 2021-01-07 dizziness Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3... Read more
Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3 hours.
33 2021-01-07 pain in extremity, lightheadedness Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. ... Read more
Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. This started at 10pm 1/6 the night of the vaccine and continued untill Friday 1/8 12 noon. It is now the evening and my arms and back are still sore.
33 2021-01-07 swollen extremities Legs were swollen; had swollen legs like edema; I had a rapid heart rate/Quick heart rate like my pu... Read more
Legs were swollen; had swollen legs like edema; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included patient had sort of allergic reaction not to a vaccine but 'a bad reaction'. There were no concomitant medications. The patient received COVID Vaccine on 18Dec2020 and ended up on Christmas she went to take a bath that was on 24Dec2020 or 25Dec2020 and noticed that her legs were all swollen and she was not used to that at all having swollen legs. She did work on her feet but she wasn't working on her feet for that week, so she just didn't know what was causing the swelling and within the last couple of days in Dec2020 she had a quick heart rate like her pulse, it's not that high but for she it was high it was like 112, 115 as her resting heart rate, so it's just been having like heart palpitations kind of, she just wanted to report that and kind of see if other people were getting that as a symptom possibly from vaccine. She had in her past had sort of allergic reaction not to a vaccine but 'a bad reaction'. She had swollen legs like edema, so she was just hoping. And then the patient stated that she wasn't tired at the starting, so she wasn't tired the same day' (could not be clarified further). No treatment was received for all events. The outcome of the events was unknown.
33 2021-01-07 pain Low-grade fever, body aches, chills, headache, and nausea Symptoms subsided after 24 hours
33 2021-01-07 pain Symptoms - ? at approximately 18:00 began with body aches, chills and febrile. EE reports Tmax 101.... Read more
Symptoms - ? at approximately 18:00 began with body aches, chills and febrile. EE reports Tmax 101. + sore throat. EE denies COVID-19 exposure without PPE and denies recent travel. EE reports she is pregnant at this time. Last day of work and shift - ? yesterday Home remedies? - 1,000 mg of Tylenol at 08:00 Any improvement? ? mild improvement Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
33 2021-01-07 dizziness Tachycardia and lightheadedness occurred about 10 minutes after injection and lasted for about 30 m... Read more
Tachycardia and lightheadedness occurred about 10 minutes after injection and lasted for about 30 minutes
33 2021-01-07 feeling hot, dizziness With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very ... Read more
With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.
33 2021-01-07 dizziness difficulty breathing, light headedness, burning on the left side of chest/was seen in the ER, sympto... Read more
difficulty breathing, light headedness, burning on the left side of chest/was seen in the ER, symptoms subsided
33 2021-01-08 pain Body aches and chills. Requiring Motrin 600mg to relieve pain. Even with 600mg of Motrin, body aches... Read more
Body aches and chills. Requiring Motrin 600mg to relieve pain. Even with 600mg of Motrin, body aches are still felt present. Relieved pain from 8/10 to a 1/10.
33 2021-01-08 pain, dizziness Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire... Read more
Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire arm radiating up neck. Day 2: fatigue, dizzy, lightheaded Day 3: vomiting Day 4: vomiting and severe headaches
33 2021-01-08 lethargy Headache, extreme lethargy, full body hives, eyes swollen . Symptoms lasted for about 48 hours.
33 2021-01-08 tremor Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was obser... Read more
Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was observed trembling. She was transported to ED (5 min transport) She was treated with: Benadryl 25mg IV X1, Solumedrol 60mg IVX1, famotidine 20mg IV X 1 - diagnoses was allergic reaction Pt improved after treatment She was observed from 09:11 until 10:33
33 2021-01-08 dizziness c/o chest pressure then lightheaded
33 2021-01-09 dizziness Fever. Chills. Dizziness. Vomiting. Cramping
33 2021-01-09 tenderness Swollen, tender axilla of right arm. Same arm as injection. The swelling started a few hours after v... Read more
Swollen, tender axilla of right arm. Same arm as injection. The swelling started a few hours after vaccine administration and remains unchanged. The area is still swollen, tender and right arm has little range of motion. Currently taking tylenol and motrin for pain. Submitting request for primary MD appointment to assess area but have not been seen by healthcare professional related to issue as of 1/10.
33 2021-01-10 feeling hot, dizziness Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swal... Read more
Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
33 2021-01-10 pain Body Aches, Chills, tiredness
33 2021-01-10 pain, weakness Chills, fever, body aches, weakness, fatigue, fever, headache. All lasting about 24hrs.
33 2021-01-10 pain Chills, fever, body aches, fatigue, head ache. Most lasting 24 hrs
33 2021-01-10 pain Fever, chills and body aches
33 2021-01-10 pain I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencin... Read more
I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencing body aches and chills. The morning of 1/9/21 I developed a fever, head ache and noticed a red, tender area the size of a penny at the injection site. During the weekend the area around the injection site continued to grow. 1/11/21 I noticed the area is itchy, red, tender/tight feeling, and warm. Pain only when the area is touch. This area is 3.5inchs W by 3 inchs L.
33 2021-01-10 pain in extremity Main in Arm , Fatigue Was tested positive for Covid 9 days later
33 2021-01-10 pain in extremity On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my... Read more
On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my left neck and arm to the point of injection site. My left arm was also sore as to be expected with typical injection but this sensation was different. It caused a sharp neuromuscular pain that was also itchy/burning. Extended in the region of sternocleidomastoid site. No rash development but seemed like symptoms of shingles. Continued through until approx 12/26/20. Improved with heat pack, Tylenol and Motrin. Was evacuated by physician on 12/21/20 with no testing or medication provided as symptoms were unclear.
33 2021-01-10 tingling, feeling cold Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down he... Read more
Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down her left arm. Her BP was recorded at 139/81, Po2 97%, pulse: 80, T: 98.8 Also right hand felt cold for 2 minutes. Prior to exit, tingling resolved. Discharged at 2:32p
33 2021-01-10 tingling, weakness, feeling cold, migraine Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills ... Read more
Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills and pins and needles sensation over entire body weakness/tiredness late afternoon
33 2021-01-10 weakness, dizziness, tingling Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on... Read more
Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
33 2021-01-10 pain She reports she had second vaccine on Jan.8th and developed a temp. 102, body aches, felt horrible. ... Read more
She reports she had second vaccine on Jan.8th and developed a temp. 102, body aches, felt horrible. She called PCP and had COVID swab 1/10 at urgent care with neg. result.
33 2021-01-10 dizziness Within 5 minutes of receiving vaccine I became diaphoretic, nauseated, dizzy, hypertensive, and tach... Read more
Within 5 minutes of receiving vaccine I became diaphoretic, nauseated, dizzy, hypertensive, and tachycardic
33 2021-01-10 pain, tremor fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever,... Read more
fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever, loss of bladder control due to uncontrollable shaking from fever, body aches. Fever up and down. Currently 48 hours out from vaccine and still overall not feeling well and currently febrile at 100.9
33 2021-01-10 pain, pain in extremity malaise, fever, total body aches, chills, fatigue, extremity pain, ankle pain, spine pain, pain at i... Read more
malaise, fever, total body aches, chills, fatigue, extremity pain, ankle pain, spine pain, pain at injection site, muscle pain
33 2021-01-10 tingling, feeling hot, dizziness patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increase... Read more
patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increased dizziness, leg weakness, tingling in thighs
33 2021-01-10 dizziness reports she had the second pfizer vaccine on Jan. 8. She did not have any reactions from the first ... Read more
reports she had the second pfizer vaccine on Jan. 8. She did not have any reactions from the first dose. Within 2 hours of having the booster she had a sore throat and HA. Saturday she had the same symptoms. Sunday = worse HA, fatigue like " i was hit by a truck" nausea and vomiting. Today, 1/11 she woke up with fever 101.3, took Tylenol and ibuprofen and it went down; dizzy and vomiting early this morning around 5am. Feeling slightly better now at 1130. However pending COVID results due to multitude of sx?s = may not be reaction to Booster, but rather actually COVID.
33 2021-01-11 pain in extremity - Arm pain after initial injection for 2 days - Significantly swollen lymph nodes on Monday after sh... Read more
- Arm pain after initial injection for 2 days - Significantly swollen lymph nodes on Monday after shot. Lymph nodes visible on left side of neck.
33 2021-01-11 pain 24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the t... Read more
24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the touch. Also swelling on L side of chest. Taking nsaid ATC but pain and swelling has persisted - pressure radiates to L scapula.
33 2021-01-11 tremor, weakness, dizziness As per Vaccine recipient -incident happened at home , Initial onset of dizziness, shortness of breat... Read more
As per Vaccine recipient -incident happened at home , Initial onset of dizziness, shortness of breath and heart racing. Then respirations were slowing and patient felt like she was going to pass out , like that pending doom sort of feeling. Patient turned very pale and was presenting black and bluish under her eye region with blue lips. At that time ,she tried to hyper ventilate herself to pink back up again, after a few minutes she regained color but was still very weak and was trembling, her respirations returned to mostly normal at that time me . She laid down to rest and then her toes started involuntarily twitching , they eventually stopped after 10-15.Whole episode lasted about half hour to 45 mins.
33 2021-01-11 pain Body aches, cough, fever
33 2021-01-11 tingling, numbness Bruising at site of injection, swelling, numbness in vaccinated arm and tingles.
33 2021-01-11 pain, dizziness Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ear... Read more
Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ears while dizzy/vomiting, injection site soreness. Vomiting subsided but other side effects remain in the afternoon the day after vaccination.
33 2021-01-11 pain I received the vaccine yesterday at 9am and I start noticing the side effects from the vaccine at mi... Read more
I received the vaccine yesterday at 9am and I start noticing the side effects from the vaccine at midnight. I had body aches, chills, fever, and now I have a headache.
33 2021-01-11 pain Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dos... Read more
Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dose number 1, 05Jan2020 Dose number 2; Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes/Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable nurse. This is the mother report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El0140), intramuscular on 17Dec2020 18:30 (dose number 1, right arm) and on 05Jan2021 18:30 (dose number 2, right arm) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified prenatal drug, sertraline hydrochloride (ZOLOFT), and acetylcarnitine hydrochloride (NEUROTIN). The patient was pregnant at the time of vaccination. No other vaccines in four weeks was taken. Patient has no COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. The patient experienced Local site pain immediately, headache, chills, fatigue and general body aches next day on 06Jan2021. 09:00. No treatment was given. Event outcome was recovering. The reporter assessed the events as non-serious.
33 2021-01-11 pain Patient describes pain at the injection site, fever, chills, headache, neck pain body aches
33 2021-01-11 pain Patient reports pain at the injection site, then developed chills and fever, body aches, muscle ache... Read more
Patient reports pain at the injection site, then developed chills and fever, body aches, muscle aches. Also reports headache and neck pain.
33 2021-01-11 pain Severe Nausea, Headache, Fatigue, Body aches. kidney stones and sore throat.
33 2021-01-11 pain in extremity Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated red... Read more
Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated redness at injection site. Area of redness was oval shaped about 2 inches in length and 1" wide. No treatment was used. Area cleared within 2 days.
33 2021-01-11 pain Woke up at 2 am to fever of 100.3, body aches, chills/sweating. Fever subsided at 10 am but body ach... Read more
Woke up at 2 am to fever of 100.3, body aches, chills/sweating. Fever subsided at 10 am but body aches and exhaustion remain. Headache present at 10 am.
33 2021-01-12 pain 01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, l... Read more
01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, lip swelling, hives. Started Benadryl at home on 01/12/2020. Seen by walk in PMD office 01/13/2021. MD prescribe, 60mg prednisone and to continue Benadryl, 50mg as needed.
33 2021-01-12 dizziness Around 12:00 pm not feeling well. Clammy, nauseated, dizzy and felt like was going to pass out. To e... Read more
Around 12:00 pm not feeling well. Clammy, nauseated, dizzy and felt like was going to pass out. To emergency department for evaluation. Treated with IV fluids and antiemetics and discharged home.
33 2021-01-12 bell's palsy, tingling, numbness Bell?s palsy Trigeminal nerve tingling and numbness started about 4 hours after vaccine. Treated wi... Read more
Bell?s palsy Trigeminal nerve tingling and numbness started about 4 hours after vaccine. Treated with prednisone and valtrex. Improved after three days on medication.
33 2021-01-12 pain, migraine Body aches, chills, migraine, nausea, fatigue >48 hours.
33 2021-01-12 weakness, tingling, dizziness Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, sti... Read more
Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, stiff joints. Went to ED.
33 2021-01-12 tenderness, feeling hot Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swe... Read more
Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swelling in left neck per employee larger than tennis ball, tender to touch,warm to touch slightly painful to touch . Size has decreased daily to now the size of tennis ball today. Did not report until today. Covid EHS notified and employee will also call them.
33 2021-01-12 dizziness Felt "heavy" and dizzy. Blood pressure was low. Observed and discharged at 1:25.
33 2021-01-12 pain Fever of 101.3, body aches and headache. Lasted 6-9hours. Treated with Tylenol and Ibuprofen.
33 2021-01-12 tingling Flush face, blotchy skin, high blood pressure, rapid pulse, tingly fingers. Given 50mg Benadryl
33 2021-01-12 pain Moderate-Severe chills, fever (maximum temperature: 101F), moderate body aches/joint pain, moderate ... Read more
Moderate-Severe chills, fever (maximum temperature: 101F), moderate body aches/joint pain, moderate headache, moderate fatigue, fainted twice
33 2021-01-12 dizziness, feeling hot PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT wait... Read more
PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT waited in observation area. While seated, she began to feel lightheaded and "hot." BP 114/70, HR 74, RR 16. Drank water on provider orders,. Neg LOC or confusion observed. STS cool air helps. By PT request, she attempted to stand which brought back symptoms. PT observed to have blanched appearance and was placed on stretcher with feet raised on 2 LPM O2, second vitals set 1115/74, HR 72, RR 18. When attempting to sit up after 15 minutes dizziness returned and nausea began. 3rd vitals set 119/79, HR 63, RR 18, O2 increased to 3 LPM by provider, PT occasionally sat up to drink water as her mouth felt dry and dizziness was persistent. 30 minutes after symptoms began, medical staff noted new onset of confusion. PT sts Sx began to resolve 55 minutes after onset. PT removed from O2 and was able to walk without aid to awaiting vehicle.
33 2021-01-12 tingling, numbness Patient reported symptoms started ~15 mins s/p dose. Symptoms reported LUE and LLE numbness/tingling... Read more
Patient reported symptoms started ~15 mins s/p dose. Symptoms reported LUE and LLE numbness/tingling, and notable tachycardia
33 2021-01-12 pain, tenderness Patient reports baseball size mass/lump to left axillary/breast area 1 day after vaccine administrat... Read more
Patient reports baseball size mass/lump to left axillary/breast area 1 day after vaccine administration. Patient states lump was sore and tender and pain aggravated by movement of left upper extremity. Lump is progressively getting smaller.
33 2021-01-12 feeling hot, dizziness Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredne... Read more
Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredness, fatigue,
33 2021-01-12 dizziness, tremor Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing st... Read more
Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies. Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water. Called 911. After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same) Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
33 2021-01-12 pain Radiating pain to underneath left arm and down left side of trunk, chills and fever. Pain is worse t... Read more
Radiating pain to underneath left arm and down left side of trunk, chills and fever. Pain is worse than just injection site pain
33 2021-01-12 pain, pain in extremity, balance disorder Started with a mild dull headache that progressed to throbbing, stabbing, headache that was aggravat... Read more
Started with a mild dull headache that progressed to throbbing, stabbing, headache that was aggravated by lights, sounds, movement. Balance was affected and was unsteady on feet, legs were weak and painful to move/stand or walk. Needed assistance to walk or move. Body chills noted that no matter how many layers applied or blankets or hot shower/bath helped. Nausea was reported but no diarrhea. Along with the leg pain, back and body aches were noted that made standing, sitting or laying extremely uncomfortable.
33 2021-01-12 pain, pain in extremity Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms las... Read more
Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms lasted 0 days
33 2021-01-12 pain, dizziness, pain in extremity Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. ... Read more
Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. Throbbing left arm at 1718. Scratchy throat at 1735. Abdominal cramping at 1740. Epi 0.3 mg IM given 1741. Transported to ED .
33 2021-01-12 feeling hot, dizziness Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She sai... Read more
Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She said she got dizzy, extremely hot and felt like she was "swaying" She said she also got what she described as "menstrual like cramps" that radiated all around her abdomen and back. She was under observation as advised per Pfizer protocol. An associate of the Pt noticed she passed out for a second she then turned beet red from her head to her neck as we could see. The associate yelled for us to grab a BENADRYL. They hooked her up to a BP machine and she did present with a spike in BP. After a few minutes, the redness and symptoms subsided. She was observed by the medical staff at the facility.
33 2021-01-12 pain fever, chills, body aches and headache x 8 hours, supportive care with Tylenol, fluids and rest
33 2021-01-12 feeling hot headache that comes and goes and was just there; Nausea; Feeling unwell; Had some fatigue as well; I... Read more
headache that comes and goes and was just there; Nausea; Feeling unwell; Had some fatigue as well; In few minutes I started feeling really hot; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: "EL324U"), via an unspecified route of administration on 03Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced headache that comes and goes and was just there, nausea, feeling unwell, some fatigue, and feeling hot. The patient took ibuprofen and acetaminophen (TYLENOL) for the headache; but did not seem to help. The clinical outcomes of headache, nausea, feeling unwell, fatigue, and feeling hot were unknown.
33 2021-01-12 tingling muscle weakness on one side of her face; On 06Jan2021 I suddenly have tingling and muscle weakness o... Read more
muscle weakness on one side of her face; On 06Jan2021 I suddenly have tingling and muscle weakness on one side of my face.; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=eh9899), intramuscularly on left arm at 07:15 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included high blood pressure and asthma, no allergies to medications, food, or other products. Concomitant medication included lisinopril and non-hormone birth control. The patient suddenly had tingling and muscle weakness on one side of her face at 07:30 AM on 06Jan2021. All events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
33 2021-01-12 numbness, dizziness per patient about 15 minutes after receiving dose she experienced some numbness in her face and some... Read more
per patient about 15 minutes after receiving dose she experienced some numbness in her face and some dizziness similar to how she feels after eating calamari. Patient was talking OK but was given 50mg oral diphenhydramine at 1:03pm, did not report feeling any worse/was feeling slightly better after 30 minutes
33 2021-01-13 feeling cold, pain Achy, feeling cold, headache, TMAX 99.8. No treatment and no improvement. Outcome: Will continue to... Read more
Achy, feeling cold, headache, TMAX 99.8. No treatment and no improvement. Outcome: Will continue to monitor symptoms.
33 2021-01-13 dizziness Approx 15 mins post vaccination began having chills, slight dizziness. Continued. Approx 2hr post v... Read more
Approx 15 mins post vaccination began having chills, slight dizziness. Continued. Approx 2hr post vaccination began having chest tightness. Approx 8hrs post vaccination began having intense joint/bone and muscle pain , rapid heart rate, shortness of breath at times. All of these symptoms continued until 1/14/21 until approx 8am. Still experiencing slight dizziness and headache.
33 2021-01-13 pain Approx 9 hours after receiving second dose of Pfizer COVID-19 vaccine, I began having uncontrollable... Read more
Approx 9 hours after receiving second dose of Pfizer COVID-19 vaccine, I began having uncontrollable chills, could not get warm, spiked a fever of 100.4, severe body aches, barely could not move. It was all I could do to finish my shift at work, drive home, get in the shower, and pass out in bed to sleep. I slept a good solid 10 hours, woke up for work...fever was then gone and chills, but I had a severe headache, still had severe body aches/fatigue, but I also lost my sense of taste and smell. I ate a waffle which tasted like cardboard, drank cranberry juice (my mouth puckered like it was tart, but I could not taste it at all). I reported to work but was immediately sent home by my employee health nurse to be seen by a health care provider and to be tested for COVID-19. I went home and slept an additional 5 hours, did not do anything at home but rest, and slept a solid 12 hours straight that night. Still could not smell and taste. The following day, I could smell things like Vicks vapor rub and I could taste things minimally like when I initially bit into them, or on the back end if that makes sense. Still had body aches and fatigue, but nothing like that previous day or the night before that. I was then told that evening my PCR test was negative, and I could report to work the following day. 1/14/2021, I felt almost completely back to normal, and I could smell and taste.
33 2021-01-13 pain Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare p... Read more
Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL1284) intramuscular in left arm on 05Jan2021 at 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Jan2021 at 19:00, the patient experienced chills, night sweats and body aches. No treatment given.The outcome of the events was recovering.
33 2021-01-13 dizziness, pain Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous repo... Read more
Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous report from a contactable other-HCP. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899), via an unspecified route of administration on 29Dec2020 11:15 at single dose for covid-19 immunisation. Medical history was none. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC). The patient experienced Chills, light headed, body aches, headache, fatigue, injection site pain on 30Dec2020 02:00. All events were non serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved.
33 2021-01-13 pain in extremity Fever, painful arm, severe headache, chills, muscle aches, initial nausea
33 2021-01-13 swollen extremities, pain First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening... Read more
First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening sore right underarm(OTC's used and alleviated symptoms) Third Day: Swollen underarm on the Right side that is painful to the touch(OTC's used, Hot/Cold compresses with little relief)
33 2021-01-13 tremor I received my first dose on 12-21-2020 and at night I had a high fever, tachycardia, tremors. I also... Read more
I received my first dose on 12-21-2020 and at night I had a high fever, tachycardia, tremors. I also had joint pain, myalgia.
33 2021-01-13 dizziness Inability to think clearly/slowed reaction time/knowing the right steps to do a process but unable t... Read more
Inability to think clearly/slowed reaction time/knowing the right steps to do a process but unable to execute timely or well Chills/freezing/cold sweats Nausea, GI distress Dizziness/lightheaded/feelings of severe dehydration/feeling unstable on feet Anterior chest burning
33 2021-01-13 tingling Tingling in extremities
33 2021-01-13 dizziness, feeling hot Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a conta... Read more
Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient not pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number unknown, via an unspecified route of administration on 08Jan2021 h 11: 00 at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive other concomitant medications within 2 weeks of vaccination. On 08Jan2021 patient experienced an extreme hot sensation and dizziness lasted a minute (within seconds I felt an extreme hot sensation and dizziness, as reported). No treatment administered for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from both events on 08Jan2021. Information on the Lot/Batch number has been requested.
33 2021-01-13 pain Woke up the morning following vaccination and had swollen lymph nodes in the armpit of the left arm.... Read more
Woke up the morning following vaccination and had swollen lymph nodes in the armpit of the left arm. Unable/painful to extend arm or move arm above head. Symptoms improved with Ibuprofen for about 6 hours and then would return. Each morning (the last 2)the symptoms have been just as severe as the first morning requiring Ibuprofen.
33 2021-01-13 dizziness, pain, difficulty speaking about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided w... Read more
about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided wheezes. I self treated with albuterol (2 puffs) inhaler that I have on hand in case of environmental allergy triggers (I rarely have to use it- last use 3 years ago). The wheezing resolved and chest pain improved but the hoarseness remained. Over the next 2-3 hours I developed headache, malaise, mild dizziness, arthralgia, myalgia, and eventually fevers and chills (by 13 hours after vaccine administration). When fever reached 101 I self treated with naproxen 250mg. I slept for 4 hours and awoke diaphoretic, but the fever had resolved and I felt much better. However, I developed urticaria that started on my flexor surfaces of the elbows, hips, and knees, and spread to my adbomen, thighs, and face, with swelling about my right eye. I self treated with 25mg benadryl and itching and urticaria improved to the point that I was able to sleep. When I awoke the next morning my symptoms had largely resolved with the exception of mild headache, body aches, hoarseness, slight chest tightness, and mild residual swelling of the right eyelid.
33 2021-01-13 pain body ache; High grade fever (102); rigors; malaise; This is a spontaneous report from a Non-contacta... Read more
body ache; High grade fever (102); rigors; malaise; This is a spontaneous report from a Non-contactable Physician. A 34 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 05Jan2021 12:00 at the second single dose (lot number EL0142), via an unspecified route of administration on 15Dec2020 17:00 at the first single dose (lot number EK5730) for covid-19 immunisation. Vaccination location was Left arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body ache, high grade fever (102), rigors, malaise on 05Jan2021 18:00. The patient did not receive any treatment for the events. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
33 2021-01-13 feeling cold body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to ... Read more
body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient). A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
33 2021-01-13 dizziness, balance disorder, pain tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache;... Read more
tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache; blurred vision at long distances; lightheadedness; occasional off balance; diarrhea; low grade fever; body aches; This is a spontaneous report from a contactable Nurse. This 33-year-old female Nurse (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), intramuscular on 05Jan2021 06:45 AM at single dose on left arm for COVID-19 immunisation. Medical history included hypertension (HTN), depression and anxiety. No known allergies. Concomitant medication included quetiapine fumarate (SEROQUEL), metoprolol, hydrochlorothiazide, lithium, alprazolam (XANAX), lamotrigine (LAMICTAL), folic acid / iron (PRENATAL), multivitamins [vitamins nos] (MULTIVITAMINS), melatonin, ibuprofen, paracetamol (TYLENOL). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Eh9899), intramuscular on 15Dec2020 07:30 AM on left arm for COVID-19 immunisation. The patient extreme headache with blurred vision at long distances (blurred vision resolved after 24 hours) lightheaded ness/occasional off balance, diarrhea, low grade fever, body aches, tactile overstimulation (having clothing or a blanket hurt and irritated her skin) on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the event blurred vision at long distances was recovered in Jan2021. The outcome of other event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
33 2021-01-14 pain in extremity 12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a f... Read more
12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day. In the middle of the night I woke up short of breath laying on my back had to lay on my side. 12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day 12/22 By the afternoon felt more normal except my arm still hurting really bad. 12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again. On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction. 12/30 my arm started itching had chills and temp right after 1/1 rapid test was negative for covid 1/2 pcr was negative
33 2021-01-14 pain in extremity, pain Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everyw... Read more
Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
33 2021-01-14 pain Fatigue, chills, body aches, sore throat, cough, congestion
33 2021-01-14 pain I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine ... Read more
I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine I had hives all Over my body which were treated with Benadryl. On Tuesday the hives persisted but treated during the day with Benadryl, at about 10:30pm the hives started to show on my face, my lips got swollen, and I felt like a pit in my throat That was stuck. I went to the ED and I was treated with IV Benadryl, IV Pepcid, and IV Solumedrol. I left the ED upon signs of improvement and was given prescriptions for Epi pen and steroids for 4 days.
33 2021-01-14 weakness Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that... Read more
Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that goes down into my hand and left side neck tightness/stiffness (muscular), upper back & B/L shoulder aching and muscular stiffness. Feels almost like a dull ?electrical shock? feeling across my upper back and down my left arm. Joint pain on the L side of my body-elbow, hip and knee. All symptoms continue into the night on day 2 after the vaccine (past 24 hrs after receiving).
33 2021-01-14 pain Intense Headache, neck ache, body ache, fever. Missed work (01/14/21) neck ache, body ache, moderate... Read more
Intense Headache, neck ache, body ache, fever. Missed work (01/14/21) neck ache, body ache, moderate headache (01/15/21).
33 2021-01-14 numbness Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a... Read more
Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female consumer received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was Mar2021) on 08Jan2021 12:30 (at the age of 33-years) as single dose, unspecified route in left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Jan2021 16:10 she started to experience numbness on the face and numbness along left side of mouth. The outcome of event numbness on the face was unknown, and numbness along left side of mouth was unknown.
33 2021-01-14 tenderness, pain in extremity, pain On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever ... Read more
On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever starting at 99.5 and by 11pm 103.5 I had body aches chills, rigers, fever did not break with tylenol or advil . I had the fever until Monday afternoon and it broke for a few hours and came back and did not budge from 101. I called occupational health and asked questions about my fever, monday night at 8pm I had a bad dry cough and SOB and chest tightness and sinus congestion, no sneezing or runny nose, still with a fever. I called occupational health again and they said to come in to get covid tested and results were positive Tuesday 29th AM. On Thursday I started taking medicine: 5 day course of singulair, slow vent albuterol prn teflex antibiotic and calcium, Zinc and Vitamin D. The fever started to break around Monday the1st to the 4th around 99 to 100 . The 4th I lost sense of taste and smell and Monday the 28, 2020 I had neuromuscular pain in stiffness in legs and I had trouble walking and when fever got lower I realized I was having pain in my feet and hips. I think the infection triggered the unknown neuromuscular condition. I was supposed to go to work the 11th but since I was still having leg issues and my leave was extended one more week. I do not believe these reactions were due to the vaccine I think it was just a coincidence I contracted COVID prior to getting the vaccine
33 2021-01-14 dizziness One day after receiving second dose of Pfizer COVID-19 vaccine, patient reported chills, muscle ache... Read more
One day after receiving second dose of Pfizer COVID-19 vaccine, patient reported chills, muscle aches, headache, diarrhea, breast tenderness/uterine cramping, dizziness. Patient was tested for COVID-19 and was negative. Patient is not currently breastfeeding, pregnant, or menstruating. Patient self-medicated with acetaminophen and ibuprofen. Fever and diarrhea resolved later on 1/8.
33 2021-01-14 pain Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1)... Read more
Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1) and advil taken. EE reports she called off of work yesterday due to feeling ill. EE reports today improvement in symptoms but still with mild HA and fatigue. Temp 99.4 today, advil taken at 13:15.? Last day of work and shift ? today Home remedies? - rest and Advil Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called off work yesterday and heading to work at time of call. EE educated on Illness in the Workplace Policy and to notify her manager if she needs to leave work and go home. EE verbalized back understanding and denied further questions at this time.
33 2021-01-14 pain Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1)... Read more
Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1) and advil taken. EE reports she called off of work yesterday due to feeling ill. EE reports today improvement in symptoms but still with mild HA and fatigue. Temp 99.4 today, advil taken at 13:15.? Last day of work and shift ? today Home remedies? - rest and Advil Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called off work yesterday and heading to work at time of call. EE educated on TCH Illness in the Workplace Policy and to notify her manager if she needs to leave work and go home. EE verbalized back understanding and denied further questions at this time.
33 2021-01-14 pain Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body ache... Read more
Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body aches. This lasted a few hours, improved with advil. After body aches subsided at around 2 AM 1/12/2021 experienced mild allergic reaction of hives and lip swelling. This allergic reaction subsided by morning 1/12 with benadryl. I have never had any side effects or allergic reaction to a vaccine. I did experience similar mild allergic reaction with antibiotic bactrim, a sulfa based medication.
33 2021-01-14 dizziness, feeling hot Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per o... Read more
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal, released home.
33 2021-01-14 feeling hot, dizziness Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per o... Read more
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal. Patient released home.
33 2021-01-14 pain With first shot just body aches; This is a spontaneous report from a contactable nurse (patient). A ... Read more
With first shot just body aches; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), intramuscular in right arm on 17Dec2020 at a single dose for covid-19 immunization. Medical history included depression. Patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced with first shot just body aches on an unspecified date. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered.
33 2021-01-14 inability to speak, pain, tingling Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a fe... Read more
Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a few hours: increased fatigue, mild ?brain fog? with some word finding difficulty, mild pressure behind eyes 3am, ~16 hours post: mild to moderate body aches, low grade fever 98-99 degrees 8am, ~21 hours post: mild body aches, back to normal temp, continued fatigue, TERRIBLE headache! 7-8/10 pain for about 10 hours. Throbbing in temples, eye pressure, pressure on top of head, worsened when I would bend over. Did not take any medication, worried it would impact immune response. Drank a lot of water, slept, did some sled massage, and gentle yoga/stretches. By that evening pain level had dropped down to about a 4. Woke up the next morning with 2-3 level pain, was able to go to work without being distracted by pain. Still felt more pressure behind eyes and top of head when I bent over. Next day all symptoms resolved, except very minor tenderness at injection site only when palpated.
33 2021-01-14 difficulty speaking fever and chills the following day, then progressive sore throat, cough and hoarseness that has last... Read more
fever and chills the following day, then progressive sore throat, cough and hoarseness that has lasted since
33 2021-01-14 pain fever of 100.9; generalized body aches
33 2021-01-15 pain Pfizer-BioNTech COVID-19 Vaccine EUA Localized inflammation, erythema, induration, swelling, pain, i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Localized inflammation, erythema, induration, swelling, pain, itching. Began on post-vaccine day one and continues into post-vaccine day two with less pain and slight reduction in swelling. Iced it on day one with some relief of swelling and pain.
33 2021-01-15 pain Rhinorrhea full body aches and pains of the long bones, chills.
33 2021-01-16 pain in extremity 1. left arm soreness, started ~8 hours after injection, lasted 48-72 hours after injection. Treated ... Read more
1. left arm soreness, started ~8 hours after injection, lasted 48-72 hours after injection. Treated with tylenol, message 2. left axillary lymphadenopathy, started about 24 hours after injection, lasted about 5-6 days after injection 3. muscle aches, started about 16-24 hours after injection, lasted about 36 hours after injection, treated with tylenol, rest 4. nausea (mild), started about 16-24 hours after injection, lasted about 36 hours after injection, treated with bland diet, hydration
33 2021-01-16 pain in extremity 1. left arm soreness. Moderate soreness. Started 12-16 hours after injection. Significant improvemen... Read more
1. left arm soreness. Moderate soreness. Started 12-16 hours after injection. Significant improvement in 48-72 hours after injection. Resolved before 96 hours. 2. left axillary lymphadenopathy. Started (or became aware of once arm soreness lessened) ~24 hours after injection. Resolved about 5 days after injection.
33 2021-01-16 pain Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after va... Read more
Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after vaccine was administered and lasted for about 18 hours
33 2021-01-16 tingling Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of v... Read more
Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of vaccination. That day she took 25 mg of Benadryl, then another 25 mg of Benadryl 5 minutes later. Her symptoms got slightly better, but she had to take another 25 mg in the evening. She reports having a headache, muscle aches and pains for 3 days after vaccination.
33 2021-01-17 dizziness 1/6/21 dizzy, nausea, photophobia- 45 minutes after vaccine
33 2021-01-17 pain in extremity Arm soreness; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant;... Read more
Arm soreness; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; Dose/Frequency: 0.3mcg IM X 1; This is a spontaneous report from a contactable Pharmacist. A 33-year-old pregnant female pharmacist reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE also reported as Covid-19 Vaccine) intramuscular left deltoid on 19Dec2020 09:10 (lot number: EJ1685; expiration date: Mar2021) at 0.3 mcg [ug] single dose and second dose was via intramuscular 09Jan2021 (unknown lot number and expiration date) at 0.3 mcg [ug] single dose for COVID-19 immunization. Medical history included ongoing seasonal allergies since 01Jan1991, ongoing pregnancy and ongoing GI health (gastrointestinal disorder). The patient reported that her last menstrual period was 10Sep2020 and estimated date of conception was 29Sep2020 and estimated delivery date is 17Jun2021. The patient's gestational period at time of initial exposure was 3 months (14 weeks, 17 weeks). The patient does not smoke, drink alcohol and use illicit drugs during this pregnancy. The patient had two live births and two C-sections with no complications. The patient has no maternal medical history and no family history of genetic abnormalities on either maternal or paternal. The patient did not have treatment for infertility. The results of serology tests (e.g., rubella, toxoplasmosis, etc) was negative. Ante-natal check-up included ultrasound at 8 weeks and at 14 weeks with both normal results. Since the patient has not delivered the baby yet, no information about the neonatal information, delivery information and baby details. There is no paternal medical history and history of genetic abnormalities. The father does not take any drugs during the wife's pregnancy. The father does not smoke or use illicit drugs during the mother's pregnancy but drinks alcohol 1 drink per week during the wife's pregnancy. History of all previous immunization with the Pfizer vaccine included MMR [Measles, Mumps, and Rubella vaccine], Tdap (Tetanus, Diphtheria, Pertussis vaccine), Varicella (Varicella vaccine), Hepatitis B (Hepatitis B vaccine) and Gardasil. Ongoing concomitant medication included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE), both since 01Jan2010 for seasonal allergies; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) since 09Jan2020 for pregnancy; and probiotics since 01Jan2015 for GI health. The patient 14 weeks pregnant at the report time. The patient volunteer to have any information collected from her be used to inform recommendations on pregnant patients receiving the covid vaccine. As of 08Jan2021, the patient reported that she did not report adverse events with the use of the product as there was no adverse event that occurred. The patient had arm soreness at 17:00. The patient did not visit the emergency room or the physician's office. The patient did not have any vaccination within 4 weeks prior to vaccination. The patient did not have lack of efficacy or a primary infection site. No antipyretic was used. The patient mentioned that she does consider the Pfizer product had a causal effect to the adverse events. The outcome of the events was unknown. The information on the lot/batch number has been requested. Amendment: This follow-up is being submitted to amend previously reported information: the coding of event 'The patient 14 weeks pregnant' was recoded from 'Exposure during pregnancy' to 'Maternal exposure during pregnancy'. Follow up (08Jan2021): New information received from a contactable pharmacist (patient) reported in response to HCP letter sent via email included: patient details, medical history, partner medical history, product details, lab data, new events (0.3 mcg single, arm soreness) and clinical course of the events.
33 2021-01-17 pain Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; ... Read more
Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
33 2021-01-17 dizziness, tingling Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has receive... Read more
Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling "off". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking. Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.
33 2021-01-17 pain in extremity Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous r... Read more
Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous report from a non-contactable nurse. This patient reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first dose the patient only had a sore arm and maybe fatigue. No treatment received for the adverse event. She was also breast feeding. Events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
33 2021-01-17 tremor allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous r... Read more
allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration (lot number: EL1283) in the arm right on 07Jan2021 09:00; at single doses for COVID-19 immunization. Medical history included known allergies: latex. Concomitant medications included magnesium oxide (MAG OXIDE) at 200 mg, daily (every day) and cetirizine hydrochloride (ZYRTEC) at 10 mg, daily (every day); and toprolol at 25 mg, every day (pending clarification for the drug). The patient previously received first dose of BNT162B2 on 17Dec2020 (lot number: EK5730) for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination; and has not been tested for COVID-19 since vaccination. Within the 15-minute observation period on 07Jan2021, the patient developed a large red itchy rash on her neck and chest area; she stated she felt fine but was observed trembling. She was transported to ED (emergency department, 5 min transport). She was treated with diphenhydramine hydrochloride (BENADRYL) at 25mg IV X1 (intravenous), and methylprednisolone (SOLUMEDROL) at 60mg IV X1 and famotidine 20mg IV X 1. Patient diagnosis was allergic reaction on 07Jan2021. Patient improved after treatment and was discharged (after being in Emergency room/department or urgent care) as she was observed from 09:11 until 10:33. Final outcome of the events was all recovered on unspecified date.; Sender's Comments: Based on the time association, the allergic reaction, rash erythematous and trembling are possibly related to suspect BNT62B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-19 feeling hot Approx. 5 min post administration recipient complained of not feeling well. On exam patient was bra... Read more
Approx. 5 min post administration recipient complained of not feeling well. On exam patient was bradycardic, diaphoretic, pale and altered. Patient appearance worsened, and level of responsiveness continued to decrease. Patient was hot and indicated difficulty breathing, and nodded in confirmation when asked if her throat felt tight. Patient given 0.3mg epinephrine IM via autoinjector in the right thigh. Patient condition improved rapidly and regained awareness. Patient transported to ER for ekg and monioting, discharged without incident.
33 2021-01-19 pain Body aches, chills, headache. Treated with Tylenol for 24 hours and symptoms have started to subsid... Read more
Body aches, chills, headache. Treated with Tylenol for 24 hours and symptoms have started to subside
33 2021-01-19 pain Client states chest tightness and throat tightness after vaccination was given. Vaccine administered... Read more
Client states chest tightness and throat tightness after vaccination was given. Vaccine administered in LA, but RA experienced soreness. Vitals taken (118/74. 99% O2, 80bpm) at 1315. Client able to verbalize that she feeling better & is able to eat and drink with no difficulties.
33 2021-01-19 pain FEVER, CHILLS, BODY ACHES, HEADACHE
33 2021-01-19 pain FROM 1/8 3AM TO 1/8 7PM: CHILLS AND BODY ACHES. TOOK IBUPROFEN EVERY 4- 6 HRS.
33 2021-01-19 pain Fatigue, body aches, chills began 1/19/21 @ about noon, following 2nd dose
33 2021-01-19 pain in extremity, weakness, dizziness Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness... Read more
Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness; muscle pain; Dizziness; Now having swelling lymph nodes under left arm; pain down entirety of the arm; This is a spontaneous report from a contactable other health care rofessional (HCP) (Patient). A 33-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular Left arm on 07Jan2021 02:00 PM at a single dose for COVID-19 immunization, Lot number: unknown. Medical history was reported as none. Patient had no known allergies. Concomitant medications were not provided. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 02:00 PM Intramuscular Left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccine within four weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. The patient received purified protein derivative (PPD) within two weeks prior to the vaccination on unknown date in Jan2021 (reported as last week), unknown results. On 08Jan2021 12:00 AM patient experienced fever night sweats, severe anxiety from 12 am -5 am, anxiety subsiding, residual fever, weakness, muscle pain and dizziness for the next 48 hours. Now having swelling lymph nodes under left arm and pain down entirety of the arm. No treatment received for the events. At the time of the report anxiety was recovering and patient had not recovered from the other mentioned events. Information on the Lot/Batch number has been requested.
33 2021-01-19 pain in extremity, swollen extremities Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left uppe... Read more
Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left upper arm edema and pain/tenderness.; This is a spontaneous report from a contactable nurse reported for herself. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231 via an unspecified route of administration on 09Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location: left arm, dose number 2, facility type vaccine: hospital. Historical Vaccine bnt162b2 (BNT162B2) Lot number EL0140 on 21Dec2020 14:45 vaccine location left arm, dose number 1, facility type vaccine: hospital. The patient medical history was not reported. There were no concomitant medications. The patient experienced left upper arm edema and pain/tenderness onset within 3 hours of receiving the 2nd dose of the vaccine. In addition: full body myalgia, fatigue, diaphoresis and fever. Symptom duration was about 12 hours. Symptoms were relieve with Tylenol and Ibuprofen. The action taken was not applicable.
33 2021-01-19 pain, weakness, dizziness, lightheadedness Onset 10-12 hours after dose on 1/18/21 Body aches, chills awakening from sleep. Fever 100.5 after a... Read more
Onset 10-12 hours after dose on 1/18/21 Body aches, chills awakening from sleep. Fever 100.5 after acetaminophen. Weakness, dizziness, mild Pre-syncope, nausea. Persisted through the night and early morning and gradually improving the next day. 24 hours after symptom onset, temp was still 99.5. Much improved with residual generalize muscle soreness upon awakening on 1/20/21
33 2021-01-19 pain Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable othe... Read more
Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable other health professional. This report involves a 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 09Jan2021 10:45 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown dose for covid-19 immunisation. On 10Jan2021, the patient experienced rash, temp of 101, body aches with outcome of recovering. The vaccine was administered at Hospital Facility. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the Lot/Batch number has been requested.
33 2021-01-19 pain Received vaccine at 0900. By 1900 employee was having body aches and headache. Symptoms improving... Read more
Received vaccine at 0900. By 1900 employee was having body aches and headache. Symptoms improving this afternoon (1/20/21).
33 2021-01-19 feeling hot approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was br... Read more
approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was bradycardic at 56, diaphoretic, hot, and altered. Patient continued to deteriorate in mental status. Patient indicated yes by nodding and clutching throat to airway constriction. Patient given .3mg epi via auto injector in the left thigh. Patient status improved markedly after adminstration. Patient taken to Er for observation and EKG. Patient was discharged without incident.
33 2021-01-20 dizziness G2P1; 19 weeks pregnant; employee felt dizzy and lightheaded after receiving her vaccine. employee ... Read more
G2P1; 19 weeks pregnant; employee felt dizzy and lightheaded after receiving her vaccine. employee given water and Cheez-Its and reported feeling much better.
33 2021-01-20 swollen extremities lymphadenopathy at her bilateral axilla.; This is a spontaneous report from a contactable pharmacist... Read more
lymphadenopathy at her bilateral axilla.; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported similar events for 2 patients. This is the first report out of 2 patients. Only this case is serious, medically significant. A 33-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date: 31Mar2021, NDC number: 59267-1000-1), intramuscular in the left deltoid on 21Dec2020 17:32 at 0.3ml single, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced lymphadenopathy at her bilateral axilla and got worse on 07Jan2021. She reported that it was painful and swollen. The events was reported as serious medically significant. She wanted to know if she should have the 2nd dose of the vaccine. The outcome of the event was not recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lymphadenopathy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : 2021025446 same reporter and drug/similar event/different patients
33 2021-01-21 pain Body aches, chills, possible fever (temperature not actually taken) On night of administration lasti... Read more
Body aches, chills, possible fever (temperature not actually taken) On night of administration lasting through second day, or day after vaccination administration
33 2021-01-21 dizziness Day after vaccine I began to have tachycardia upon standing and walking. Heart rates are in the 140-... Read more
Day after vaccine I began to have tachycardia upon standing and walking. Heart rates are in the 140-170s when walking a normal pace. Resting heart rate is much higher than normal at around 100. When climbing stairs, heart rate gets into the high 170s. Shortness of breath and dizziness accompany standing, walking and climbing stairs. These symptoms still persist - have been ongoing from 11/12/21 - 11/22/21.
33 2021-01-24 tingling, pain After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on ... Read more
After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on left cheek likes pins and needles poking my face; next day the blisters popped and created crater on my skin and area was getting bigger and it was oozing and I felt that stinging poking on that affected area. Next day after that, I went to my dermatologist for a consultation and he said it was Herpes Simplex. Along with that, 2 days after the blisters started appearing on my face, before I went to my dr's office - was having 101. fever, chills, body aches , and severe cough with vomiting and not able and so I got tested the day I went to my Dr. and it was a negative COVID test. Treatment: Antiviral medication for one week; Topical ointment: Bacteralban ointment; I still have the face color with the Herpes was.
33 2021-01-24 feeling cold, pain, tremor, lethargy At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. ... Read more
At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. My temperature was 102, then my fever rose to 104.5 for most of the night. I did not sleep because my body was shaking and shivering. My body ached all over, especially my lower back. It felt like a very bad flu. My fever continued onto the next day and stayed around 103.7. I slept most of the day- had to call out of work. Tuesday morning my fever was gone and I went to work then went home because my fever spiked again to 101 about mid day. I slept all day and took Tylenol. By Wednesday my Fever was gone but I was still very lethargic. Thursday I felt fine.
33 2021-01-24 pain Body aches, chills
33 2021-01-24 pain Developed severe body aches, chest pain and shortness of breath. High fever, reaching 103.3. Fever a... Read more
Developed severe body aches, chest pain and shortness of breath. High fever, reaching 103.3. Fever and symptoms lasted 72 hours with little relief with Tylenol or Ibuprofen. I called into PCP and he stated that because I recently had COVID, my immune response to the vaccine was exaggerated.
33 2021-01-24 pain Nausea, body aches, chills, headache
33 2021-01-24 dizziness Pain at injection site, Dizziness, fever, chills, all over muscle pain, Headache, left armpit lymph ... Read more
Pain at injection site, Dizziness, fever, chills, all over muscle pain, Headache, left armpit lymph node swelling and soreness
33 2021-01-24 feeling hot, dizziness passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode... Read more
passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
33 2021-01-25 pain, pain in extremity Approx 8 hrs after injection i developed sore arm. After that my entire body began to ache, mild at ... Read more
Approx 8 hrs after injection i developed sore arm. After that my entire body began to ache, mild at first and then like I had been hit by a truck. Around 10 pm I developed chills and the feeling I couldn't get warm and felt exhausted. Sore body and chills lasted all night, I developed a fever sometime in the night and when checked was 101.9. Took 2 doses of tylenol to bring it down to 99. Ive been sweating profusely, severe headache, accelerated heart rate reaching 100 bpm at complete rest along with feeling exhaustedand body aches that lasted all day and into the night. It is now 930 am on the 26th and I feel better. Still sweating and body aches mildly with some tiredness.
33 2021-01-25 feeling hot Body felt on fire Headache and severe Joint pain
33 2021-01-25 pain Chills; Fevers; minor body aches/severe body aches; small headache/severe headaches; This is a spont... Read more
Chills; Fevers; minor body aches/severe body aches; small headache/severe headaches; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a single dose for COVID-19 immunization. The patient's medical history included sub clinical hyperthyroidism and diagnosed with COVID prior to vaccination. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the left arm on 21Dec2020 11:45 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 12Jan2021 20:00, the patient experienced minor body aches and a small headache. She went to bed and woke up at approx. 13Jan2021 00:15 with severe body aches, severe headaches, chills, and fevers. Therapeutic measures were taken as a result of the adverse events and included treatment with ibuprofen and diphenhydramine (BENADRYL). Outcome of the events was not recovered.
33 2021-01-25 lightheadedness, dizziness, pain For her feeling like she was going to pass out, patient states that she was probably dehydrated; Rig... Read more
For her feeling like she was going to pass out, patient states that she was probably dehydrated; Right sided Neck Pain and Right sided armpit pain; Right sided Neck Pain and Right sided armpit pain; right side neck swelling; Felt like going to pass out; Felt light headed like she was going to pass out; Nausea; Vomiting; Upset stomach; Body chills and aches; Body chills and aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: 31Mar2021) solution for injection, via an unspecified route of administration on right arm on 11Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient was not pregnant. Patient reported she got the first dose on 20Dec2020 and on an unknown date in Dec2020, she experienced right side neck pain, right side armpit pain, arm pain where she received the vaccine on the right side, right neck swelling, tenderness, and lymph node thing. Patient reported that on 11Jan2021, she got the second dose at 9AM and by 5-6 PM she felt the symptoms. Then by 7:30PM felt terrible and had to have her sister come get her, she felt like she was going to pass out. She experienced the nausea before 7:30PM on 11Jan2021. The vomiting happened on 11Jan2021 at night 12 hours after the vaccine, she vomited the next day also around 10 in the morning on 12Jan2021. The upset stomach started 11Jan2021. Patient confirmed that she did not actually pass out but she felt light headed like she was going to pass out, it started on 11Jan2021 and went into 12Jan2021 she was just light headed and not well. The body chills aches started 11Jan2021 around the 5-6PM time, she felt fine most of the day but it was that evening she was achy. The headache started 11Jan2021 at night continued to 12Jan2021 and was still ongoing today. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She stated that she was probably dehydrated and still feels like she was recovering. She had right side neck swelling on 11Jan2021 and right sided under armpit pain on 12Jan2021. She has never been tested for Covid or had any antibody tests. She has had no issues with vaccines in the past. Outcome of the events 'Felt like going to pass out', 'Nausea, Vomiting', 'Upset stomach', 'Body chills and aches' was recovered on 12Jan2021; 'Headache' and 'dehydrated' were recovering; 'Right sided Neck Pain and Right sided armpit pain' was not recovered; 'dizziness' and 'right side neck swelling' were unknown. No follow-up activities are needed. No further information is expected.
33 2021-01-25 numbness, pain Swollen lymph node in underarm of injected arm. About the size of a nickel, mildly painful when I mo... Read more
Swollen lymph node in underarm of injected arm. About the size of a nickel, mildly painful when I moved and causing slight numbness down my arm. The pain upon moving/numbness went away after a couple days. Swollen lymph still present as of today, mild and periodic throbbing pain still persists.
33 2021-01-25 pain in extremity The next day, Friday January 22, 2021 around midday both of my legs began to ache in my thighs. Ove... Read more
The next day, Friday January 22, 2021 around midday both of my legs began to ache in my thighs. Overnight it went away and I was fine Saturday and I worked a 12hr shift 7am to 7pm. Sunday I worked from 7am to 3pm and my legs started to ache when I got home around 4:30pm until 10pm when I went to bed.. I had to take some ibprofen that evening. I was again fine all day Monday. Now today 1/26/2021,my legs began to ache again this morning around 8:30am.
33 2021-01-25 dizziness Within an hour but after the 30 minute waiting period the patient began to experience lightheadednes... Read more
Within an hour but after the 30 minute waiting period the patient began to experience lightheadedness, flushing, and nausea. Recieved 50 mg of IM benadryl(works in medical facility). Patient improved and was discharged to family.
33 2021-01-25 pain, tenderness, pain in extremity fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lum... Read more
fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lump near right side of neck, next to clavicle. Ibuprofen for body aches taken sunday , Monday. Today Tuesday 1-26-21 continues with soreness to right underarm, injection site and lump on neck.
33 2021-01-26 pain Approximately 12 hours after shot I experienced high fever, chills, body aches and headache. Symptom... Read more
Approximately 12 hours after shot I experienced high fever, chills, body aches and headache. Symptoms lessened with Tylenol and have since returned. Fever now low grade, body aches and headache are mild.
33 2021-01-26 pain Body aches, no treatment, 8-10hrs malaise, no treatment, 12-24hrs
33 2021-01-26 pain, pain in extremity I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little b... Read more
I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little bit fatigued. Symptoms lasted about 24 hours. I had a little arm soreness too and that lasted two. Pregnancy: May 4 expected due date and totally normal pregnancy.
33 2021-01-26 tingling, numbness Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, like... Read more
Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, likened to "arm being asleep and waking up". Writer performed stroke assessment due to patients reported symptoms. Assessment negative. Assessment of injection site negative. Patient remains A&O x4 (person, place, time, and situation). Patient reports improvement with continued movement with arm. Patient released to self to home after reported symptoms subsided - ~30 minutes from start to finish
33 2021-01-26 pain Started with body aches at first, severe chills and fever (101.1) all throughout the night, headache... Read more
Started with body aches at first, severe chills and fever (101.1) all throughout the night, headache, nausea. Currently (46 hours later) - body aches, temperature of 100.2.
33 2021-01-26 pain in extremity, tenderness right neck swelling; tenderness; it was a lymph node thing; right sided Neck Pain; Right sided armpi... Read more
right neck swelling; tenderness; it was a lymph node thing; right sided Neck Pain; Right sided armpit pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received the first dose of BNT162B2 (lot number: EH9899, Expiry Date: 15Dec2021) via an unspecified route of administration in right arm on 20Dec2020 at single dose for COVID-19 immunisation. She received the second dose on 11Jan2021. There was no medical history. There were no concomitant medications. The patient got the first dose on 20Dec2020. It was after the second dose she had symptoms. The second dose was on 11Jan2021. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She further clarifies that she actually had this symptom on Dec2020 after the first vaccine dose also, she had the right neck swelling and tenderness, the same side as where she got the vaccine on. When she got the First Dose on 20Dec2020 she had the right sided neck pain and arm pain on Dec2020 she received the vaccine on the right side, she was going to the ear doctor asking about it, it occurred about 2 days after the first vaccine dose and hung around a long time, it lasted more than a week, she guess it was a lymph node thing. She has never been tested for COVID or had any Antibody tests. She has had no issues with vaccines in the past. The patient was not pregnant. Events outcome of right sided Neck Pain and Right sided armpit pain was not recovered, while for others was unknown.
33 2021-01-26 seizure seizure after vaccine
33 2021-01-28 weakness Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; ... Read more
Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, intramuscular on 09Jan2021 16:45 at single dose on left arm for COVID-19 immunization. The patient is not pregnant and has no medical history, no known allergies and no prior vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). The patient experienced joint aching and feeling of weakness in forearms, fingers, left hip and toes; not actively exercising on 13Jan2021 at 14:00. The patient had no treatment received. The outcome of the events was not recovered.
33 2021-01-28 seizure Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along... Read more
Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along with Ativan when needed
33 2021-01-28 dizziness Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate. pharmaci... Read more
Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate. pharmacist gave 1 dose of IM EPI in the L thigh
33 2021-02-01 pain, dizziness Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21... Read more
Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
33 2021-02-04 dizziness, pain Fever, body pain, headache, joint pain, nausea, dizziness, diarrhea, swollen pelvic glands and right... Read more
Fever, body pain, headache, joint pain, nausea, dizziness, diarrhea, swollen pelvic glands and right axilla
33 2021-02-07 dizziness Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and co... Read more
Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and could not get out of bed without almost falling over and very nauseated. Symptoms eventually subsided around 10:00 am. Did not have dizziness again. Had a confirmatory Ultrasound on 2/4/21 which measured 5weeks, 5 days and no yolk sac. Was supposed to be 7 weeks, 5 days. Determined that I miscarried.
33 2021-02-11 numbness LEFT ARM NEUROPRAXIA/NEUROPATHY ... PATIENT WITH COMPLETE NUMBNESS TO LEFT ARM, WEAKNESS TO LEFT ARM... Read more
LEFT ARM NEUROPRAXIA/NEUROPATHY ... PATIENT WITH COMPLETE NUMBNESS TO LEFT ARM, WEAKNESS TO LEFT ARM.
33 2021-02-14 tingling Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead ski... Read more
Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead skin got tight and dry, now I've lost vision in my right eye! Today is exactly 2 weeks after 1st vaccine and sight in my right eye is worse and painful
33 2021-02-16 tingling Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this ... Read more
Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this time at 2200 temp was 103.7 took Advil at this time. Temp stayed 102-103.7 with Tylenol and Advil round the clock until 2/8/21 around 1300 at this time temp had gone down to 101. Noticed once fever started to drop my left toes started to tingle. Tingling got worse over the next few days until 2/11/21 my whole leg went extremely heavy (could not lift at all). Admitted to hospital 2/12/21.
33 2021-02-16 tingling, dizziness, numbness, speech disorder, nerve pain, pain, vertigo, inability to speak Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal.... Read more
Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal. Sore throat, fluid in ears and lungs. Muscle weakness, headaches...difficulty walking. Insomnia. Flu like symptoms for 2 weeks after dose2. Nerve pain (shooting sensation down both arms. Difficulty standing for more than a few minutes, light headed. Ear pain, nausea, night sweats and unable to grasp normally. Tingling in face. Numbness in face.
33 2021-02-16 dizziness vaccine is really taking a big toll on her brain function; feels just weird, like everything is in s... Read more
vaccine is really taking a big toll on her brain function; feels just weird, like everything is in slow motion/feeling really weird; dizzy/lightheaded; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left deltoid on 02Feb2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient got the COVID vaccine a couple hours ago on 02Feb202 and was very lightheaded. When the patient was asked to provide her mailing address, she stated she was feeling really weird, the vaccine was really taking a big toll on her brain function, she was super dizzy and feels just weird, like everything is in slow motion. Lightheadedness started probably about 20 minutes after she had the shot, they made her wait for 15 minutes, now she just feels really weird. The patient was healthy, she just got blood tests back and everything said she is healthy. She thought they said to call if she was having a side effect of dizziness or weakness, as they are more serious, but she called her doctor and they said to call Pfizer. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date.
33 2021-02-21 pain For about 8 hours on the day after I received the second shot, I experienced sweats (no chills) and ... Read more
For about 8 hours on the day after I received the second shot, I experienced sweats (no chills) and (possibly) a fever. I felt slightly achy and tired. I did not have pain at the injection site or any difficulty lifting my arm.
33 2021-02-21 numbness, tingling Grávida 2. EDD:7/15/21. Numbness/tingling to face for about 45 min.
33 2021-02-21 pain Left foot swelling joint and some pain
33 2021-02-21 tremor, dizziness Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency r... Read more
Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency room where a patient developed minimal residual erythema
33 2021-02-21 dizziness Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Deve... Read more
Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Developed itchy red rash across chest ~8 minutes after administration. This began to fade ~15 minutes after administration, but patient then complained that tongue felt funny & began clearing throat. After consulting with our NP, Epipen was administered (0.3mg), & 911 called. Transported via ambulance ED. Pt reported tongue feeling better after Epipen.
33 2021-02-21 vertigo poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt micr... Read more
poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt microdosing benadryl, inhaler
33 2021-02-22 dizziness "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine. He began to... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine. He began to feel dizzy and faint at 11:41 am. His vitals were 134/86, 20, 82 at 11:41 am. We applied chill towel to back of neck. B/P 104/84,20, 84 P, 98 % RA. 11:46 am. Individual report that he did not have breakfast and did not hydrate. Patient swallowing intact. He was given bottle of water. 1:58 pm vitals were 114/82, 99% SATS, 99, 18. Individual stated she felt better and was no longer dizzy. 2:04 pm vitals 118/84. 18, 72, 98% RA. After drinking 32 oz of water individual went home with family with no noted distress.
33 2021-02-22 numbness, tingling, pain in extremity Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm s... Read more
Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm symptoms lasted approximately 48 hours from on-set. Also experienced fatigue, headache and arm soreness
33 2021-02-22 pain, weakness Whole body aches, fatigue, headache, weakness
33 2021-02-23 feeling hot Pt complained of itching and warm feeling no sob or dizziness. Was evaluated by EMS, they recommende... Read more
Pt complained of itching and warm feeling no sob or dizziness. Was evaluated by EMS, they recommended giving liquid benadryl 25mg. Pt vitals sign BP 132/78 R 20 P 78 o2 97%. PT reported feeling better after receiving the benadryl waited an additional 30 mins before leaving. Refused any other treatment.
33 2021-02-23 numbness, pain in extremity have had intermittent right neck pain and right hip/back pain, radiating to right leg since receivin... Read more
have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; numbness at times in her right foot; This is a spontaneous report from a contactable nurse reporting for herself. A 33-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EK9231, via an unspecified route of administration on 28Dec2020 16:45 (33 years old) as a SINGLE DOSE for COVID-19 immunization. Medical history included High blood pressure from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included sertraline, melatonin, colecalciferol (VITAMIN D), folic acid, iron (PRENATAL). The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021, the patient experienced have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine. Patient also had some numbness at times in her right foot on 07Jan2021. She has not been able to see her primary care provider but has an appointment in Feb to be evaluated. The events were non-serious. No treatment was received for the events. Outcome of the events was not recovered. The patient received the second dose on 19Jan2021 in the Left arm lot EL3302.
33 2021-02-25 pain in extremity sore arm for two days; This is a spontaneous report received from a non-contactable consumer (patien... Read more
sore arm for two days; This is a spontaneous report received from a non-contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, in Jan2021 (lot number and expiry date unknown), at single dose, for covid-19 immunization, at the hospital. There were no medical history and concomitant medication. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. The patient experienced sore arm for two days in Jan2021. Treatment included two doses of Advil. The patient recovered from the event in Jan2021. No follow-up attempts are possible; Information about lot and batch number could not be obtained. No further information is expected.
33 2021-02-28 numbness, tingling, facial paralysis brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and ti... Read more
brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9264 and Expiration Date: May2021), via an unspecified route of administration in the left arm on 02Feb2021 at 17:45 at 33-years-old at a single dose for COVID-19 immunization; with no other vaccines administered within four weeks of the bnt162b2 administration. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date to an unspecified date, prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to 16Feb2021. The patient experienced the following events and outcomes: Bell's palsy on left side of face (medically significant) on 06Feb2021 12:00 with outcome of recovering, vision has been off/ vision is blurry (medically significant) on 06Feb2021 12:00 with outcome of recovering, numbness and tingly/burning sensation in right leg (medically significant) on 06Feb2021 12:00 with outcome of recovering, brain fog (medically significant) on an unspecified date with outcome of unknown; all of which required a physician office visit. The clinical course was reported as follows: The patient received the first dose of the Pfizer COVID 19 vaccine, she began having symptoms on the following Saturday and was seen by her doctor and diagnosed with Bell's Palsy. The patient stated she has reported this via VSafe and the Pfizer website. The patient also reported other symptoms that have not been reported as follows: had tingling in both legs, brain fog, and vision has been off. The patient was not sure if it was related to the vaccine or steroids. The patient wanted to know if she should get the second dose. The patient had been on a steroid, so she did not know if she should wait to get the second dose. The patient just stopped the steroid on 16Feb2021, and the second dose was scheduled for 23Feb2021. The patient also said she had other symptoms that she had not reported and she said she had tingling that started in one leg now in both legs, brain fog and her vision was off and she was not sure if that was related to the vaccine or the steroid (later clarified as prednisone). The patient was not taking the steroids at the time of diagnosis. "Correct I mean it started after the vaccine, but I was also on medication (Clarified as Prednisone) so I am not really sure what the difference is at this time." Treatment in response to event: the patient stated, "No I mean for the tingling in my leg I have been just putting heat and Ice on it but I have not done anything actual big treatment and then for my eyes no, my doctor is not sure what is related to the Bell's Palsy and what is to medication." The patient underwent lab tests and procedures which included lab work: unknown result on an unspecified date (patient stated, "Yes, I have many"). Therapeutic measures were taken as a result of facial paralysis, hypoaesthesia, burning sensation, and paraesthesia; which included steroids and anti-viral and anti-nausea medicine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
33 2021-02-28 pain, feeling hot she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a... Read more
she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).
33 2021-03-02 pain The individual felt neck, back and shoulder pain. Symptoms started 1-18-2021. On 1-31-21 she wen... Read more
The individual felt neck, back and shoulder pain. Symptoms started 1-18-2021. On 1-31-21 she went to hospital and was admitted on 2-1-21 with nausea, chilss, headaches, vomiting, and body aches. COVID-19 test was reportedly negative. All tests were normal.
33 2021-03-02 dizziness, pain, speech disorder, vertigo Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normal... Read more
Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-03-02 pain headache; nausea; low grade temp/fever; body aches; chills; This is a spontaneous report from a cont... Read more
headache; nausea; low grade temp/fever; body aches; chills; This is a spontaneous report from a contactable nurse (also the patient). A 33-year-old (also the age at vaccination) female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration at the left arm on 24Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient first dose was given on 03Jan2021 02:00 PM at the left arm (lot: EL3246) for covid-19 immunization. The patient was vaccinated at a Public Health Department (also reported as Public Health Clinic/Administration facility). The patient is not pregnant. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, norethisterone (VYFEMLA), collagen and unspecified multivitamin and anti-allergy (reported as received within 2 weeks of vaccination). It was reported that the patient experienced low grade temp, fever, body aches, chills on 25Jan2021 at 04:00 AM, then fever, headache, nausea on 26Jan2021 and also headache on 27Jan2021. No treatment was received for the adverse event. The outcome of the events was recovered in Jan2021. The case/ events were considered as non-serious
33 2021-03-09 pain body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was ... Read more
body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was coming on/was going to get a headache; her arm hurt/arm pain/iced the injection site; never falling back asleep; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 15:15 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. After 2nd vaccine. The patient felt fine most of the evening and through the night. The patient woke up in the middle of the night around 3/3:30 am (totally normal for her) and felt fine except for some arm pain on 05Feb2021. The patient iced the injection site, but by 4:30/5 the patient was still awake and now felt like she was going to get a headache (also common for patient). The patient took her temperature (was normal), took 2 Tylenol (5am), and went back to bed (but never falling back asleep). The patient left for work at 6:45am. The patient felt totally fine, even energetic, most of the morning. The following day at 10 am caller reported body aches and feeling feverish but no fever. At almost 10am exactly, her back started aching and by 10:30 the patient had full body aches and started getting chills. The patient left work at 11am, was home before 12pm with a temperature of 98.5, took 2 more Tylenol and napped. The patient had no symptoms the rest of the afternoon until 5pm when the back aches returned. Took 2 more Tylenol. The patient napped later in the evening, too, but took 2 more Tylenol at 10pm before going to sleep for the night. Woke up Saturday morning without symptoms. The outcome of events was recovered in Feb2021. Information about Lot/batch number requested.
33 2021-03-21 vertigo I started experiencing innappropriate affect and lost control of emotions. I would cry innappropriat... Read more
I started experiencing innappropriate affect and lost control of emotions. I would cry innappropriately or laugh at things innappropriately. I began experiencing brain fog and memory loss. Then i began experiencing vertigo that impaired my spacial reasoning. On Tuesday 3/9 I lost the ability to see objects far away. on 3/10 I woke up and was unable to read close up, or distinguish letters. The vision and vertigo has continued. I have to shut my eyes completely to walk without becoming sick. I can not be in a busy room with movement or my eyes will hurt. I can not read anything with font smaller then size 18. I can not watch TV because i can no longer see far away. I can not drive a car due to the motion., and i cant see the objects as they move.
33 2021-04-06 unresponsive to stimuli On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unrespo... Read more
On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired.
33 2021-04-06 migraine, dizziness, pain the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was ... Read more
the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
33 2021-04-08 bell's palsy Bells Palsy. Started 1 hour and 20 minutes after my second vaccine dose was administered. Currently ... Read more
Bells Palsy. Started 1 hour and 20 minutes after my second vaccine dose was administered. Currently hospitalized and having tests run.
34 2020-12-31 dizziness Chills, fatigue, muscle aches, fever with period of sweats, swollen neck lymph nodes, dizzy, diarrhe... Read more
Chills, fatigue, muscle aches, fever with period of sweats, swollen neck lymph nodes, dizzy, diarrhea, pounding headache. Symptoms have started to occurr on 12/28, until now jan 1st, 2021. It consumes my whole body, to eve. Get up from bed or even walk 10ft to the bathroom. Its very difficult, I am a single mom with 3 kids.
34 2020-12-31 numbness I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a... Read more
I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a moderate pounding headache. Around 4:30pm, I noticed minor unilateral scalp, facial and neck numbness on the left side. These symptoms lasted about a week, but slowly improved. Four days after the vaccine I had very tender lymph nodes on the left ear area. Today marks two weeks exactly since I received the vaccine and two days ago I noticed slight increase in numbness on the left cheek again which again, is slowly improving. However, I also wear Invisalign at sometimes notice that I bite my cheek while asleep. I also wear N95 masks four days of the week which are quite tight on the face. The injection site (Left deltoid) was moderately sore for the first few days and still two weeks later has minor soreness the comes and goes.
34 2020-12-31 dizziness, feeling hot, tingling It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way tow... Read more
It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way towards my torso. I started to feel flush and my heart rate rapidly increased. I felt it was nothing so i tried to calm myself and watch my heart rate on my watch and it continued to increase. It started at 100 and within a minute was at 130. I finally honked my horn for assistance and my symptoms continued. I became very faint and nauseous and felt as though i was going to throw up. open my door and took my mask off to help with getting air and it didn't do much to help. I felt very light headed and uncomfortably closet o passing out than i ever have. This lasted for a good 10 minutes until it slowly passed. Faint, nauseous, hot and rapid heart rate of 130 were my main symptoms and were very uncomfortable.
34 2020-12-31 pain Patient reported one day post immunization moderate body aches, headache, severe throbbing injection... Read more
Patient reported one day post immunization moderate body aches, headache, severe throbbing injection site.
34 2021-01-01 tingling Received the Pfizer COVID-2019 vaccine and within 5 minutes developed tingling and felt like pins an... Read more
Received the Pfizer COVID-2019 vaccine and within 5 minutes developed tingling and felt like pins and needles in the ring finger and hand of the arm injected (right arm). Started to improve about half an hour later, completely resolved within 2 hours. I was evaluated by our employee health services NP and my HR was slightly elevated but no other concerning symptoms noted.
34 2021-01-02 tingling, vertigo Approximately 1 week following vaccination, patient developed new onset of right sided hemisensory l... Read more
Approximately 1 week following vaccination, patient developed new onset of right sided hemisensory loss and paresthesia with feeling of mild vertigo. This worsened over the following 4-5 days prompting patient to come to hospital on January 3, 2021 for further evaluation.
34 2021-01-02 tingling, numbness, dizziness At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting gene... Read more
At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting generalized headache 6/10. States that she has not eaten any food today except coffee. BP 88/49. HR 45 Patient was laid flat and legs elevated. Repeat BP 1613 101/59. Patient reported bilateral arms feeling "cold".   O: Patient alert and oriented, following commands, no focal weakness. BUE cool to touch.   EMS called at 1609. ED arrival 1620. Repeat VS 1620 105/65 HR 55   Upon EMS arrival patient declined to receive further treatment and signed AMA paperwork.   Discussed with patient to return to ED for any further worsening of symptoms.
34 2021-01-02 pain I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, ... Read more
I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, itching in the throat and mouth and a swollen uvula. I was given multiple doses of Benadryl and steroids. The next day I developed a temperature of 102 degrees and had a severe headache, nausea, and body aches. The headache and fatigue are still present now 4 days later.
34 2021-01-02 pain Left shoulder/arm muscle soreness Left pectoral muscle soreness Tender, swollen lymph node The pain ... Read more
Left shoulder/arm muscle soreness Left pectoral muscle soreness Tender, swollen lymph node The pain in the Left shoulder and across Left chest is persistent and flares with exertion. Tender, swollen (presumed) lymph node directly under Left collar bone and to the left of sternum, pain persistent when at rest and flares when exerting force with Left arm (lifting/pushing/pulling), pain when taking deep breathes.
34 2021-01-02 pain in extremity, pain On Tuesday 12/28 I started to have severe leg pain in my right leg. The next morning the pain was s... Read more
On Tuesday 12/28 I started to have severe leg pain in my right leg. The next morning the pain was still in the right leg and had moved up through my right side in my joints to my knee, hip then went to the with shoulder down that arm. My forearm became very painful on 12/30 and started to swell then radiated into my wrist joint and finger joints. 12/31 the pain continued in all those areas and had moved to my left side of my body starting with the left arm following the same course as the right side. On 1/1 the pain has persisted and I am unable to perform any ADL's. I saw an urgent care physician who told me to take ibuprofen. I have been taking ibuprofen and Tylenol with no relief. Now all my joints are swelling in bilateral hands, wrist. On 1/2 my bilateral ankle joints and feet started to have similar pain. Know all my extremities are difficult to use and it is hard to walk due to the pain. Because of the pain in my hands things feel heavier than what they should. I am a medical provider and this almost seems like polyarthralgia rheumatica, I am going to go see a physician on Monday
34 2021-01-03 numbness 12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and signifi... Read more
12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and significant weakness and numbness of left arm, weak hand grip, clumsiness in hand . Did not improve after trying to shake arm/move around , and took prednisone 40mg oral. Went to ER and had CT Cspine which did not show evidence of cervical pathology. Continued with corticosteroids, sought consultation with PMR and neurology specialists, and steroid dose increased to 60mg/day. Some improvement in strength , but still have diminished sensation and strength in left hand/arm. Unable to perform full job tasks as I am left hand dominant. Likely brachial neuritis / parsonage turner syndrome per both specialists seen. Continuing with corticosteroids at this time, pending bloodwork and OT evaluation
34 2021-01-03 dizziness, pain COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 1... Read more
COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 12/30/21- moderate pain in upper arm and sharp, stabbing pain in axilla (injection site side). Unable to lift arm straight up due to pain. Evening: Myalgia/joint pain, fatigue, nausea, mild headache. Took Tylenol and Phenergan. 12/31/21- Woke up at 4am with pain in axilla-took tylenol. Moderate pain in upper arm and axilla. Unable to palpate axilla due to pain while at work. Evening: axillary lymphadenopathy noted- walnut sized. Severe myalgia/joint pain, fatigue, nausea, headache, malaise. Took Motrin and Phenergan. Woke up in middle of night with pain in arm/axilla and nausea. took tylenol and zofran. 1/1/21- Worst day of symptoms. Moderate-severe pain in upper arm and axilla. Golf ball sized lymphadenopathy in axilla on injection side. Severe weakness, dizziness, fatigue, myalgia, and joint pain. Low grade temp (99.7), tachycardia (HR averaged 110-115), shortness of breath on exertion with associated tachypnea (RR 24-26). No appetite and nausea. Stayed in bed ALL DAY. Alternated Tylenol/ Motrin, Benadryl & Zofran as needed. Only reason I did not go to ED is because I had a pulse oximeter at home was monitoring O2 sats closely. Never de-sat'ed. Had I not had the pulse ox at home, I would've gone to ED. In the evening, had lymphadenopathy in neck also (same side as injection). 1/2/21- Most symptoms have dissipated except axillary lymphadenoapthy- axilla incredibly tender-golf ball sized. Lymph nodes in neck still palpably enlarged. 1/3/21- Lymph nodes in neck normal. Axillary lymphadenopathy remains with same tenderness. 1/4/21 AM- NO change in axillary lymphadenopathy-tenderness same
34 2021-01-03 dizziness, feeling hot Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her... Read more
Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her upper chest and arms/ heavy legs and arms/really heavy arms and legs; experienced a weird heaviness on her upper chest and arms; really cold hands; felt really hot at the injection site/really hot sensation at injection site; lightheadedness/Light-headed; Palpitations; Feeling faint; shortness of breath; Her blood pressure went up to 134/100; paleness; went up to her face; felt tired/She was really tired and slept it off; This is a spontaneous report from a contactable nurse, who is also the patient. This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing asthma (diagnosed as a teenager with sports asthma and uses an inhaler). There were no concomitant medications. The patient experienced lightheadedness/light-headed (medically significant) on 20Dec2020 with outcome of recovering, palpitations (medically significant) on 20Dec2020 with outcome of recovered on 20Dec2020, feeling faint (medically significant) on 20Dec2020 with outcome of recovered on 22Dec2020, flushing (medically significant) on 21Dec2020 with outcome of recovered on 22Dec2020, she noticed that there was a ringing in her left ear (medically significant) on 21Dec2020 with outcome of recovering, shortness of breath (medically significant) on 20Dec2020 with outcome of recovering, her blood pressure went up to 134/100 (non-serious) on 20Dec2020 with outcome of recovered on 20Dec2020, she experienced a weird heaviness on her upper chest and arms (non-serious) on 21Dec2020 with outcome of recovering, really cold hands (non-serious) on 21Dec2020 with outcome of not recovered, paleness (non-serious) in Dec2020 with outcome of unknown, felt really hot at the injection site/really hot sensation at injection site (non-serious) on 21Dec2020 with outcome of recovered on 23Dec2020, went up to her face (feeling hot) (non-serious) in Dec2020 with outcome of unknown, heavy legs and arms/really heavy arms and legs (non-serious) on 21Dec2020 with outcome of not recovered and felt tired/she was really tired and slept it off (non-serious) in Dec2020 with outcome of unknown. The patient specified that she experienced a moderate reaction after having the COVID-19 vaccine. She had the vaccine last Sunday morning 20Dec2020. She was told to wait 20 minutes before leaving. In the waiting area, she felt lightheaded, had palpitations and was feeling faint. After 20 minutes she started feeling better. Then she started to have more intense light headedness. She went to the ER and was given oxygen. Her blood pressure was 134/100 on 20Dec2020. She had an EKG on 20Dec2020 that was normal. They gave her steroids and Benadryl. She had another episode while being injected with the steroids. On Monday 21Dec2020, she experienced a weird heaviness of her upper chest and arm. She had really cold hands and flushing. On Monday night 21Dec2020 she went to work. She experienced a really hot sensation to the injection site that went to her neck and face. Her left ear was ringing. This lasted until Tuesday 22Dec2020. She took Benadryl again on Tuesday 22Dec2020. She had shortness of breath which started on 20Dec2020 and on 22Dec2020 she had shortness of breath that lasted until 11am. She had really heavy legs and arms and went back to the ER. She had a chest X-ray and D-dimer on 22Dec2020 that were normal per the ER. The night before the report, she had some of the same symptoms. She was really tired and slept it off. She didn't take anything. The morning of the report, she was feeling good and better. She still has heavy feeling on upper chest and arms. Caller clarifies that she did not have a heavy feeling in her legs. Her arms feel heavy if she holds her phone too long. She continues to have ringing in her ear. The flushing went up to her face. The patient specified that she developed sports asthma as a child and uses an inhaler. She gets short of breath if she overexerts herself. Additional laboratory investigations on 20Dec2020 included blood work with unknown results and Troponin which was normal. She was provided with a general steroid. She did not know the name of it. She was also given Benadryl and monitored on telemetry. She was given IV fluids again on 22Dec2020.; Sender's Comments: Based on the compatible temporal association and the known pattern of response, the Company considers the reported events are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-03 dizziness, feeling hot Hot and lightheaded
34 2021-01-03 feeling hot, tingling, swollen extremities Patient received Pfizer COVID vaccine 0.3 mL IM x1 on 1/4/2021 @0808. Patient had NKDA and was obser... Read more
Patient received Pfizer COVID vaccine 0.3 mL IM x1 on 1/4/2021 @0808. Patient had NKDA and was observed for 15 minutes after administration with no adverse reactions observed. Patient returned to work and noticed swelling in left arm around 0900. Patient returned to clinic complaining of left sided arm tingling and feeling hot. Also edema to ear lobe and arm. Patient given Benadryl 50 mg po x 1 liquid @0916. No sign of respiratory distress, blood pressure 134/84, and no other signs of advancing allergic reaction.. Patient discharged to husband @1021.
34 2021-01-03 pain in extremity Slight headache a few ours later after vaccination. The next morning I had headache, some joint/mus... Read more
Slight headache a few ours later after vaccination. The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)
34 2021-01-04 dizziness Dizzy, headache, felt faint, high HR, felt off - few episodes for about 30 min after injection
34 2021-01-04 feeling hot, pain in extremity Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved... Read more
Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved by Tylenol through the following Tuesday (5 days after vaccine). Hot flashes are intermittent. Also feel fatigued starting Saturday 1/2, improved 1/3, worsening 1/4 into 1/5. Sore arm for about couple days, very mild.
34 2021-01-04 pain, dizziness Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a ... Read more
Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, cough, body aches, headache, back pain, dizziness, increased heart rate, insomnia at 01:00 PM on 24Dec2020. All events were reported as non-serious. The patient received Tylenol as treatment. The outcome of events was unknown. The patient was not diagnosed COVID prior vaccination, patient was not tested COVID post vaccination. Information about lot/batch number has been requested.
34 2021-01-04 pain in extremity, pain Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other ... Read more
Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other health professional (patient). A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 24Dec2020 09:15 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, fatigue, body aches, sore arm from 24Dec2020 21:00. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
34 2021-01-04 dizziness, weakness Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatig... Read more
Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatigue; Body weakness like uncontrollable fatigue; severe stomach pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 30Mar2021), via an unspecified route of administration on 27Dec2020 at single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis and fibromyalgia. Concomitant medication included duloxetine hydrochloride (CYMBALTA) as thyroid medication (when probed for thyroid medication, consumer stated, "CYMBALTA." (Indication was not clarified further)) and the patient also took her thyroid medications, medication for fibromyalgia. Consumer stated that she just got the COVID vaccine, her first COVID vaccine yesterday (27Dec2020) and she was experiencing some side effects that were more severe than just pain in my arm. When clarified if had pain in arm, consumer stated "No", she was experiencing light headedness, dizziness, feeling like I am going to faint, severe stomach pain, body weakness like uncontrollable fatigue in Dec2020. The outcome of the events was unknown.
34 2021-01-04 nerve pain Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lowe... Read more
Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), via an unspecified route of administration on the right arm on 18Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included Gyn issues, migraine and headaches but otherwise healthy. The patient also had allergies with sulfa, leminine, and latex sensitivity but not anaphylactic. Concomitant medications included elagolix sodium (ORILISSA), and calcium carbonate, colecalciferol, phytomenadione (VIACTIV). It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 14:00, the patient experienced nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
34 2021-01-04 pain called in sick 12/30/20, having fever, chills, body aches, cough, sore throat, and headache, tested ... Read more
called in sick 12/30/20, having fever, chills, body aches, cough, sore throat, and headache, tested for COVID 1/4/2021 it was Negative
34 2021-01-05 pain in extremity, pain 1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fev... Read more
1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fever, body aches, headache fatigue
34 2021-01-05 pain 1/6/21: 1245 am. Chills. Fever, headache, body aches, fatigue 1/6/21: 1:30pm tmep 99.7, body aches.... Read more
1/6/21: 1245 am. Chills. Fever, headache, body aches, fatigue 1/6/21: 1:30pm tmep 99.7, body aches. Fatigue. Chills
34 2021-01-05 pain, tremor, feeling cold 12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so... Read more
12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so severe I had a difficult time walking. My injection site (Left deltoid) was swollen and sore, although not more than usual after receiving a vaccine. I had no headache at all. The major concern was the fever and the backaches. I could not get warm, and I was shaking badly because I was so cold. I had ZERO relief despite taking 700 Mg of Tylenol. Side effects finally subsided after about 5 hours.
34 2021-01-05 dizziness Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up... Read more
Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up with pcp
34 2021-01-05 tingling, pain, pain in extremity, numbness At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up in... Read more
At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up into the left shoulder and down the left arm. A numbness and tingling sensation has continued in the left arm and then all over the body- bilateral upper and lower extremities intermittently since time of injection until current. The sensations are occurring randomly about every 1 minute. No associated muscle weakness or any other neurological changes. Patient has been referred to a neurologist for further evaluation and management.
34 2021-01-05 numbness, tingling Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This... Read more
Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
34 2021-01-05 dizziness Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have pa... Read more
Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have patients describe migraines where noises make them feel dizzy, but I did not get a headache. Movements, lights and noises made the symptoms worsen. I was feeling better by the 21st and now symptoms have resolved.
34 2021-01-05 pain Fever up to 102 accompanied by headache, fatigue and significant body aches. Onset of severe symptom... Read more
Fever up to 102 accompanied by headache, fatigue and significant body aches. Onset of severe symptoms about 12.5 hours after administration, treated with Tylenol (1gm q6H) and ibuprofen 600mg q6H alternating. Fever initially unresponsive to antipyretic. 24 hours post-administration has decreased to 99.4.
34 2021-01-05 pain in extremity Left armpit pain without mass for 4 days, delayed reaction that did not start until 7 days after vac... Read more
Left armpit pain without mass for 4 days, delayed reaction that did not start until 7 days after vaccine. Initial vaccine reaction w mild sore arm on side of vaccine
34 2021-01-05 numbness, tingling The day after the vaccination, woke up at 0600 and noted numbness and tingling down right lower extr... Read more
The day after the vaccination, woke up at 0600 and noted numbness and tingling down right lower extremity from thigh down to toes. Leg was completely ?asleep? and unable to bear weight. Lasted for approximately one hour. Tingling in extremity lasted throughout day and continued for about 1 week. Also noted minor tingling in left toes and right side of face.
34 2021-01-05 tingling face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous r... Read more
face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous report from a contactable healthcare professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 28Dec2020 at 17:30 (at the age of 34-years-old) at a single dose for COVID-19 immunization. Medical history included sulfonamides allergy. The patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks prior to vaccination, included ascorbic acid (VIT C; MANUFACTURER UNKNOWN), curcuma longa (TURMERIC), and collagen (MANUFACTURER) taken as supplement. Additional concomitant medications included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously took azithromycin (MANUFACTURER UNKNOWN) and experienced allergy and vortioxetine hydrobromide (TRINTELLIX) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tingling that started at nose and spread across cheeks and lips on 28Dec2020 at 18:00 and face puffy on 29Dec2020. The events were reported as non-serious. Therapeutic measures were taken as a result of tingling that started at nose and spread across cheeks and lips, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling that started at nose and spread across cheeks and lips was recovered in Dec2020 and of and face puffy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-01-06 pain in extremity 1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered t... Read more
1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min
34 2021-01-06 numbness, tingling 12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUM... Read more
12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUMBNESS AND PRESSURE ON L CHEEK, TINGLING OF LIPS ON L SIDE, HA ON L SIDE. WENT TO THE ER AROUND 5PM. I TOOK SOME IBUPROFREN, TYLENOL. 12/23 SOMEWHAT RESOLVED FOLLOWING WEEK; SWOLLEN LYMPHNODES ON L SIDE , BACK OF HEAD. COVID TEST; NEGATIVE
34 2021-01-06 dizziness Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mi... Read more
Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mins.; Mental confusion; couldn't gather my thoughts or write what I wanted to say; mental 'fog'; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm, on 28Dec2020 13:15 at single dose for COVID-19 immunization. Medical history allergy to penicillin. The patient is not pregnant during the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and cefalexin (KEFLEX) and experienced allergies to both. The patient experienced mental confusion, mental 'fog', "couldn't gather my thoughts or write what I wanted to say", also had dizziness while sitting down (felt like I would have fallen if I stood up so I sat for 20mins) all on 28Dec2020 at 13:15. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 28Dec2020 at 13:45 (reported as events subsided after 30 minutes). The reporter assessed the case as non-serious.
34 2021-01-06 pain Body Aches and chilling
34 2021-01-06 pain in extremity Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore... Read more
Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore arm that's getting better. Red, inflamed, hot to touch at injection site. 1in x 2in in size.
34 2021-01-06 feeling hot, dizziness Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for... Read more
Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for a moment (I had to stop the procedure I was doing in order to sit down and drink some water). I kept trying to hydrate and had a headache the rest of the day and it went through the evening and night. I did not take anything and went to bed with the headache and woke up and felt fine.
34 2021-01-06 pain Fever 104.0F, chills, aches
34 2021-01-06 pain Fever, aches, headache, Tylenol and rest. Recovered after 1 day
34 2021-01-06 pain Headache, chills and significant body aches (back, neck, arms, legs) starting about 4 hours after ad... Read more
Headache, chills and significant body aches (back, neck, arms, legs) starting about 4 hours after administration.
34 2021-01-06 pain, pain in extremity, dizziness Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbea... Read more
Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbearable pain in that arm. Ended up with a trip to the ER with diagnoses of cellulitis to the right arm, (same as vaccinated arm). Currently taking antibiotics.
34 2021-01-06 tingling, numbness, dizziness Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling... Read more
Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling light-headed briefly. Narrative: Patient sat through most of anticipated monitoring time without incident, the reported tingling and numbness developing on the right side which fairly quickly expanded to entire body. Reported mild light-headedness. Continued to monitor closely without other intervention required. Patient stood up, reported feeling better and resolution of symptoms with that movement. Continued to monitor a few more minutes. Patient left area symptom-free at 12:00 with teaching of appropriate calls to make or where to return to should she be further symptomatic.
34 2021-01-06 feeling hot Myalgia all over the body, headache, nausea, vomiting x1, intermittent sheivering and feeling hot
34 2021-01-06 tingling, numbness Patient reported tingling and numbness to one side of face and spreading down her neck. Patient tra... Read more
Patient reported tingling and numbness to one side of face and spreading down her neck. Patient transferred to E.D. for observation.
34 2021-01-06 pain Very mild headache on day of admin of 2nd dose. Difficulty sleeping. Then awoke with intense body ac... Read more
Very mild headache on day of admin of 2nd dose. Difficulty sleeping. Then awoke with intense body aches at 3am could not go back to sleep. Muscle and joint pain, body aches, and intermittent headache with pressure. Still experiencing.
34 2021-01-06 numbness numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus patholog... Read more
numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-06 tingling peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous ... Read more
peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at Left arm on 22Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine and multivitamin. No other vaccine in four weeks. The patient was not sure if this was related to the vaccine or not. The patient didn't know if anyone else was having peripheral neuropathy type symptoms such as tingling of the feet, legs, hands, arms. The symptoms started a few days ago. The patient did not even sure if it related to the vaccine. Adverse event start date was 27Dec2020. Covid was not tested post vaccination. The outcome of the events was not recovered. No treatment received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The temporal relationship between the onset of the event and administration of the vaccine does not support a causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-01-07 difficulty speaking AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE ... Read more
AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED. C/O DIFFICULTY BREATHING. DENIED FEVER, CHILLS OR BODY ACHES. MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF. SENT TO ER WITH DIFFICULTY BREATHING.
34 2021-01-07 tingling Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swel... Read more
Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swelling. Wednesday much worse lymph node swelling and right side of face with some swelling. Tingling began and bumps with red line formed on forehead. Thursday-same except swelling I'm lymph nodes was so painful it woke me up. Today, Friday January 8th I went to a doctor's care. Diagnosed with shingles.
34 2021-01-07 difficulty speaking Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soren... Read more
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included severe dust mite allergy (based on skin test). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening. The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-07 pain Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after... Read more
Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after vaccination, started feeling joint pain. Continued to work until the end of shift 1930. took Benadryl at 32130. Fell asleep; awoke next morning with aches; nasal congestion. Took Sudafed & came to work again (12/18/2020, 0700). Face started itching; then arms @t 0800 but continued working and finished shift. took Benadryl to relieve itching. Awoke early in morning to severe itching. Increased dose of Benadryl and fell asleep. Continued itching on Sat 12/19/2020 and having difficulty breathing. Used inhaler, Pepcid and Prednisone with good effect. Took off work Monday 12/21/2000, Tues 12/22/2020 and Wed 12/23/2020 (no meds taken). Returned to work on 12/24/2020, no fever, no exposure
34 2021-01-07 dizziness Called immunization line and left message. Called client back. Complaining of generally not feeling... Read more
Called immunization line and left message. Called client back. Complaining of generally not feeling well; extremely dizzy; HA; nausea; vomiting; diarrhea on 1-8-2021
34 2021-01-07 pain in extremity, weakness, numbness, pain For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyac... Read more
For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyaches, low back pain, intermittent neck pain. Following day I had the same symptoms in addition to left sided axillary lymphadenopathy w/ numbness of L hand 4th & 5th fingers and mild cough. Currently I am about 52 hours post vaccine with left sided axillary lymphadenopathy and intermittent numbness of left 4th and 5th fingers. Other symptoms have improved.
34 2021-01-07 tingling, dizziness Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset o... Read more
Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset of lightheadedness within 5 minutes of vaccine followed by nausea. After 35 min she felt tingling on her face and felt like her throat was numb. She drank water with no problem. She checked her O2 sat and it remained 91 - 93%. She just had an O2 meter because her Mother-in-law gave it to her. No underlying lung problem. She continues to have mild nausea but other symptoms have resolved. She has been able to eat some food which is making her feel better. She says she is developing tenderness in her temples which feels like she's developing a headache.
34 2021-01-07 dizziness, lightheadedness Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from ... Read more
Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from a contactable physician. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration on 20Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced near syncope, lightheaded, dizzy, vision narrow and tingling in lips on 20Dec2020 09:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the events. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
34 2021-01-07 numbness, tingling Numbness and tingling over entire body. Settled to left side. Still present 9 days post vaccinatio... Read more
Numbness and tingling over entire body. Settled to left side. Still present 9 days post vaccination.
34 2021-01-07 pain On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30... Read more
On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30 min; felt fine and left. At 0745, I started itching and developing a headache (on my drive home). At 0800, restricted breathing; took 50 mg of Benadryl (resolved) and 1000mg acetaminophen for headache (unresolved). At 1200, 99.6 F temp with unresolved headache and felt nausea; took 4mg Zofran. At 1300, took 1000mg acetaminophen; temp was 101 F and stomach felt upset so I didn't want to take ibuprofen At 1900, took 1000mg acetaminophen, temp 100.2F; tried to have some soup; my stomach upset and hurts and feels worse with food At 2200, tempt 99.8 F; stomach hurts; achy; itchy; took 600 mg ibuprofen and 50 mg Benadryl
34 2021-01-07 tingling Paresthesia in lips, hands and feet 15 mins to 3 hours post vaccine Narrative:
34 2021-01-07 pain in extremity Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, ne... Read more
Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Range of motion highly affected not responding to self treatments or other meds; This is a spontaneous report from a contactable nurse reporting on herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Dec2020 at 11:00 AM (at the age of 34 years old) as a single dose for COVID-19 vaccination. Relevant medical history included anxiety. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected. not responding to self treatments or other meds. The events resulted in a physician's office visit. The patient did not receive any treatment for the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back. The patient received treatment for the event range of motion highly affected but it was not responding to self-treatments or other medications. The outcome of the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
34 2021-01-07 pain Severe pain, tenderness and swelling in L axillary, Ibuprofen, Tylenol and warm compress to site eff... Read more
Severe pain, tenderness and swelling in L axillary, Ibuprofen, Tylenol and warm compress to site effected
34 2021-01-07 tingling, numbness The following was reported by the vaccinated individual: I received my first dose of Pfizer Covid v... Read more
The following was reported by the vaccinated individual: I received my first dose of Pfizer Covid vaccination in my right deltoid on Monday January 4, 2021. 30 minutes post injection I began experiencing numbness and tingling in my left cheek, left arm and hand, and left leg & foot. This continued on Jan 5th. On Jan. 6th the symptoms resolved.
34 2021-01-07 dizziness Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/... Read more
Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/97 Heart Rate 78 Respiratory Rate 16 Temp 36.9 °C (98.4 °F) Temp src Oral SpO2 97 % 34 y.o. female who arrived by From on-campus presented to the emergency department for an allergic reaction to the Pfizer COVID-19 vaccine. Pt received the first round of injections at 1707 tonight and experienced adverse reactions. Pt endorses dizziness which is accompanied by central abdominal pain and itching of her left thigh. Pt states that her throat is dry, but adds that it could be from not drinking much fluids today. Pt has a hx of anaphylaxis from shellfish and angioedema. She says these current symptoms are not similar to the ones she experienced from anaphylaxis or angioedema. Pt has not started or changed any medications, but had an IUD inserted about a week and a half ago. Pt denies any fevers, chills, coughs, cold symptoms, chest pain, palpitations, shortness of breath, headaches, nausea, vomiting, bowel or bladder problems, or urinary complaints. Clinical exam shows central abdominal pain just above the umbilicus with itching of the posterior aspect of the left lateral thigh. Will administer PO Prednisone and PO Diphenhydramine in the ED and observe the pt. No epinephrine injection was deemed necessary at this time. DDx: allergic reaction 1910 hours: Discussed further treatment and vaccine advice with the pt. Will discharge pt to home. Provided follow up instructions to her PCP, for reevaluation. Discussed return precautions. Vital signs are stable at time of discharge.
34 2021-01-07 dizziness, tingling a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated... Read more
a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-07 involuntary muscle movements about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became t... Read more
about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became tingling and a bit numb. Soon right after my heart rate was very fast, highest 160's. My throat felt weird but I never had any difficulty swallowing or breathing and my mouth, lips, or tongue never became swollen.
34 2021-01-07 tingling increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry
34 2021-01-07 migraine, pain soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migr... Read more
soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose, for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021. .
34 2021-01-08 tingling, facial paralysis At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow a... Read more
At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip. As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse. Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors.
34 2021-01-08 pain Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itch... Read more
Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itchiness developed 4 hrs after injection Other symptoms were Muscle and body aches Slight cough Sore throat Face puffy Fatigue Chest heaviness (o2 levels stayed 100 percent )
34 2021-01-08 feeling cold Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hou... Read more
Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hours. Symptoms include fever (Tmax 104 F) unresponsive to antipyretics, chills, severe myalgias, headache, and sore throat.
34 2021-01-08 pain body aches, chills, headache, subjective fever
34 2021-01-08 pain fever at 12h and 28h after vaccine, profound body aches (muscle, joint, headaches) that were debilit... Read more
fever at 12h and 28h after vaccine, profound body aches (muscle, joint, headaches) that were debilitating and could not go to work
34 2021-01-09 dizziness, pain in extremity 1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible fro... Read more
1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible from technique vs actual vaccine 1807 - Neck pain, 3/10, left arm pain 3/10. Left cervical lymph node inflamed 2035 - ringing on right ear 2244 - dizziness 1/9/21. Injection site 1cm diameter bump. Pain in left arm, neck, shoulder 1156 - headache, sharp right parietal 3/10 1730 - pain 8/10 on left upper arm, radiating to lower arm, shoulder, neck. Improved to 4/10 after Advil 800mg once. 1/10/21. Woke up with pain in left arm 7/10. Injection site has induration of 4cm, reddened, warm, tender to touch. Pain improved after Advil 800mg and Tylenol 500mg
34 2021-01-09 pain in extremity, pain 16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injec... Read more
16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injection: body aches increase, chills, fever (Tmax 101.2 36 hr post injection: back to normal baseline state
34 2021-01-09 migraine 20 hours after injection: Injection site soreness Fever Night sweats Back pain Fatigue Migraine
34 2021-01-09 pain, migraine, dizziness At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe b... Read more
At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe body aches, Hips, and knees were the worst. Paid scale would be 8/10. at 16 hours added fever was 102.5 , sever headache over the whole head, at hour 24 same. Hour 36 fever is down to 99.7 however, muscle paid have subsided and migraine is better. Pain scale 3/10
34 2021-01-09 pain in extremity Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spr... Read more
Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spread throughout her body.
34 2021-01-09 dizziness, migraine, pain Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches... Read more
Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches.
34 2021-01-09 pain Fever, chills. Body aches
34 2021-01-09 tremor, pain I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what fel... Read more
I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what felt like electrical jolts in my body. One time I woke up jumping so high of my bed that it felt like I was being tased. I woke up the next morning and felt like electrical currents were running through my body. My right hand had a tremor too
34 2021-01-09 dizziness Sudden onset Severe muscle ache, joint pain, diaphoretic, lightheaded, fever, nausea, fatigue. Appro... Read more
Sudden onset Severe muscle ache, joint pain, diaphoretic, lightheaded, fever, nausea, fatigue. Approximately 24 hour duration. Acetaminophen administration with resolution of fever but no effect on other symptoms.
34 2021-01-10 feeling hot, feeling hot About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feel... Read more
About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feeling warm. Burning sensation followed up to left side of face. Second dose of injection given on left side. Patient states she has a scratchy throat. Vitals taken at 1311: 98.9, 152/98, HR 80, 99% on room air. 50mg IM Benadryl given at 1312 in right deltoid. Laid patient down on stretcher. Patient also stated she developed cold like symptoms after her first Covid vaccine injection, and tested negative for Covid. Vitals rechecked again at 1322: 130/86, 99% on room air, pulse 75. Told patient to say for another 15 minutes in waiting room. Patient left at 1345. Patient stated the burning and warmness had gone away.
34 2021-01-10 feeling hot After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose... Read more
After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose: bad headaches that wouldn't go away with NSAIDS, chest pain, hot diaphragm, fatigue. She reports still having these symptoms and it is day 4 after the vaccine.
34 2021-01-10 pain Fever, chills, body aches
34 2021-01-10 pain I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed... Read more
I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed a 100.4 temperature and malaise and body aches. The injection site was swollen, tender to touch and warm. The injection site area remained tender to touch and I was unable to lie on my left side to sleep for over 48 hours. I continued to feel foggy and fatigued for 48 hours. All symptoms have since resolved.
34 2021-01-10 weakness Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sle... Read more
Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sleep
34 2021-01-10 numbness, weakness Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in... Read more
Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
34 2021-01-10 dizziness, weakness Patient became dizzy, nauseous, weak, and had a headache within 2 hours of vaccination.
34 2021-01-10 dizziness Patient had no issues with the first injection. States she felt like her face was burning, she was h... Read more
Patient had no issues with the first injection. States she felt like her face was burning, she was having trouble breathing, and felt light headed. Denies any prior anaphylactic reactions, denies vagal experiences after blood draws. Symptoms started within 5 minutes of the vaccination. Vistaril given, patient monitored for one hour in the emergency department with no further incident and returned to work,.
34 2021-01-10 feeling hot, tingling Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm".... Read more
Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm". Resolved quickly once patient received Benadryl 100mg.
34 2021-01-10 tingling, feeling hot Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm"... Read more
Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm". Patient was medicated with Benadryl 100mg and felt fine after a short period of time.
34 2021-01-10 pain extreme body aches and fever aprox 24 hours after vaccine, lasting aprox 24 hours
34 2021-01-10 dizziness felt a rush of dizziness to my head / felt a little lightheaded all day; heart started racing over 1... Read more
felt a rush of dizziness to my head / felt a little lightheaded all day; heart started racing over 150 bpm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140), via an unspecified route of administration in the left arm on 04Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included overweight and elevated cholesterol. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 04Jan2021 08:00, the patient felt a rush of dizziness to her head a few minutes after receiving the injection and then her heart started racing over 150 bpm. It calmed down after a few minutes although she have felt a little lightheaded all day. No treatment was received for the adverse event. The events were considered non-serious by the reporter.
34 2021-01-10 pain fever and body aches beginning at 2AM. treated with Ibuprofen with resulting reducting in fever but ... Read more
fever and body aches beginning at 2AM. treated with Ibuprofen with resulting reducting in fever but continued body aches/myalgias that lasted until 1pm on 1/10/21. Fatigue starting 5pm 1/9 and lasting until 5pm 1/10
34 2021-01-10 pain fever, body aches
34 2021-01-11 dizziness, difficulty speaking -0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it wa... Read more
-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine. Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived (delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About 0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay resolved. -Made follow up appointment with Primary Care Physician per protocol
34 2021-01-11 numbness 3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx tha... Read more
3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx that self-resolved within 5-10 minutes. Also developed paresthesias of bilateral hands and feet with stomach discomfort.
34 2021-01-11 pain, pain in extremity, numbness 40 minutes after the vaccine administration, I experienced numbness on the right side of my face. A... Read more
40 minutes after the vaccine administration, I experienced numbness on the right side of my face. Around my eye, to the side of my nose and around my mouth, only on the right side. Also on the right side of my tongue. This resolved after an hour and a half. It reoccurred about 6 hours later, at 4:00 p.m. . And continued for 48 hours. 12 hours post vaccine, a fever as high as 102 degrees Fahrenheit, severe body aches targeting especially the lower extremities, and chills occurred. The fever and chills lasted 24 hours. The body ach es lasted 48 hours.
34 2021-01-11 dizziness After vaccination patient started complaining of itchy throat. She then stated she was dizzy and th... Read more
After vaccination patient started complaining of itchy throat. She then stated she was dizzy and that there was a lump in her throat. A few minutes after that she stated it was hard to swallow. She also complained about tingling around her lips and had some swelling of her lips. Pt was then given epinephrine and taken to the emergency room.
34 2021-01-11 weakness During the overnight hours after recurrent my vaccine i developed fever, cold, and headache. All ... Read more
During the overnight hours after recurrent my vaccine i developed fever, cold, and headache. All day I have had a low grade fever up to 100.9 as well as headache and weakness/ fatigue.
34 2021-01-11 feeling hot, dizziness Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded... Read more
Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded. Blood pressure was elevated >180/90, HR 110-120. Gradually decreased and at approximately 30minutes post injection, blood pressure was <145/90 and HR 84. Took 25mg of benadryl approximately 1 1/2 hour after injection time. Symptoms persisted mildly for another 30-45 minutes after benadryl and seem to be gone 5 hours later. Blood pressure 5 hours after was 134/85 which is still a slight elevation from my norm.
34 2021-01-11 pain Fever, Body aches, muscle aches, headache
34 2021-01-11 feeling hot, numbness, tingling, weakness I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs an... Read more
I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs and arms. And numbness to the left side of my face. I felt like my heart was beating fast. The administrator gave me bendryl. I felt better, but I felt weak. I was able to go home 2 hours after the administration.
34 2021-01-11 tremor I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itchi... Read more
I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication. Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications. The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15. The events were reported to have resulted in emergency room/department or urgent care. The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination. The outcome of events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
34 2021-01-11 dizziness, pain I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours af... Read more
I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours after dose had body aches. 2 days after dose I had blurred vision in Rt eye and then noticed that Rt eye was fully dilated and Lt eye was normal. Rt eye not responding to light. Went to ED and had 2 CT scans that were normal. They sent me where I had a third CT scan which was normal. I saw ophthalmology and my optic nerve was normal and eyes looked good, but Rt eye still didn't react to light. they ruled out pharmacological and said that it is something neurological. They still don't know exactly what is going on. While at the hospital, I started having urinary retention and now have a foley placed. I have follow ups with neurology, urology and ophthalmology and have orders for MRI of brain and neck.
34 2021-01-11 pain Low grade fever, headache, body ache
34 2021-01-11 dizziness, weakness Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fat... Read more
Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fatigue
34 2021-01-11 pain Patient vaccinated on 1/5/21 in am. Reports onset of symptoms on 1/9/21. Patient says she experien... Read more
Patient vaccinated on 1/5/21 in am. Reports onset of symptoms on 1/9/21. Patient says she experienced body aches, involuntary head nodding that she describes similar to muscle twitches. Patient reports chills with no fever, nausea and diarrhea that has not stopped. She also described pain in her spine that wrapped around into her chest like a sharp shooting pain and fatigue and a headache that feels like a band wrapped around her head. Symptoms started 1/9/21 and are still present 1/12/21.
34 2021-01-11 pain in extremity Temperature to 100.2, sore arm, fatigue
34 2021-01-11 pain chills, body aches, headaches
34 2021-01-11 pain in extremity feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Sore... Read more
feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medications included fluticasone propionate for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-01-12 pain 14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches. Mond... Read more
14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches. Monday 1/11 through today 1/13 still feeling feverish with chills and body aches but no actual fever and deep dull back pain that is making me vomit. Also injection site redness started 48hrs after vaccine and only continues to worsen and spread each day still today 1/13. Have been taking Tylenol, Motrin, antihistamine, and at times Zofran.
34 2021-01-12 pain 8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to rai... Read more
8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to raise arm above shoulder level and painful to move and touch. (resolved) 3 days following vaccine: Sudden onset chills, fever of 101.1, myalgia throughout body and fatigue. I slept for 14 hours straight, still have slight fever of 99.6 and some myalgia, but mostly resolved.
34 2021-01-12 dizziness, pain, numbness After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks ... Read more
After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks After 2nd dose : lightheaded myalgia fever axillary lymph node swelling and redness, nausea, body aches for two days. Still on day four currently : lightheaded/severe dizziness and fatigue
34 2021-01-12 pain All of these symptoms began on 1/13/21: Chills, headache, fever (100.2-101.0 deg F), nausea, body ac... Read more
All of these symptoms began on 1/13/21: Chills, headache, fever (100.2-101.0 deg F), nausea, body aches, chest pressure, metal taste in my mouth, fatigue
34 2021-01-12 pain Approximately 16 hours after injection, experienced body aches, chills, severe headache and fatigue.... Read more
Approximately 16 hours after injection, experienced body aches, chills, severe headache and fatigue. Symptoms resolved after approximately 14 hours later.
34 2021-01-12 vertigo, dizziness, pain in extremity Beginning 12 hours after my 2nd dose, I woke up with myalgias, chills, and drenching sweats on 1/9. ... Read more
Beginning 12 hours after my 2nd dose, I woke up with myalgias, chills, and drenching sweats on 1/9. Later that morning 6:30am, I developed severe fatigue, dizziness upon standing and walking, a L sided headache, L sided arm pain extending from elbow to sternocleidomastoid muscles on the L side, and axillary lymphadenopathy in the same arm as the vaccine (left). I took 650mg of Tylenol and went to work. Walking at a normal pace, my heart rate was 145. At rest inside the hospital it was in the 110s (measured by watch). the headache lasted all day on 1/9 and 1/10 and my neck felt slightly stiff (it was difficult to turn my head to look at traffic behind while driving). I took additional doses of Tylenol on 1/9 and 1/10 and by the AM of 1/11, all of my symptoms had resolved except for the L axillary lymphadenopathy.
34 2021-01-12 pain Fever; headache; body aches; This is a spontaneous report from a non-contactable other healthcare pr... Read more
Fever; headache; body aches; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), via an unspecified route of administration on 05Jan2021 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (results unknown). The patient experienced fever, headache, body aches an unspecified date in Jan2021. Event outcome was unknown. The reporter assessed the events as non-serious. No follow up attempts are possible. No further information is expected.
34 2021-01-12 pain in extremity Headache, L arm soreness, full body muscle pain, full body joint pain, severe fatigue, diarrhea
34 2021-01-12 pain Hives to bilateral breasts, self resolved after 3-4 hours (Have bilateral silicone breast implants).... Read more
Hives to bilateral breasts, self resolved after 3-4 hours (Have bilateral silicone breast implants). Patient also had fever, body aches and headache.
34 2021-01-12 pain in extremity I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & mal... Read more
I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & malays. My estimated date of deliver is 03/05/2021 and I am 32 weeks gestation.
34 2021-01-12 tingling, numbness I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left ... Read more
I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left side of my face was numb and tingling. I am able to move it but is continuing to tingle only on my left side. My lips, the very side of my tongue, my bottom jaw and my check bone constantly tingle and feel numb, when I talk some spit comes out on that side and my side of my nose also feels numb. As time goes on it isn't getting any better but not much worse. today my bottom lip just feels more numb
34 2021-01-12 pain in extremity, feeling hot, numbness, tingling, pain LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode o... Read more
LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode of burning across chest x 1 when symptoms first started. Brief period of muscle spasms along left neck, back left arm and left lower extremity on first day of vaccination. Brief episode of right hand numbness and tingling. On day 2 very flushed and hot feeling, temp 37.9 at 1am on 01/12/21. Sever muscle spasms and pain from left trapezius to sternocleidomastoid, to left upper extremity, left thorax and abdomen to left lower extremity with extreme fatigue. Headache throughout day. Now with residual left lower extremity numbness and tingling, pain improved and muscle spasm frequency decreasing although episode of chest pain with muscle spasm did occur yesterday evening. At this point the left lower extremity tingling is most worrisome. Muscle spasms and pain slightly improved.
34 2021-01-12 numbness, pain, tremor, pain in extremity Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was... Read more
Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was given the vaccine at 0915 today and about 5 mins after started to have symptoms of a hot sensation from head to toe, heart racing, ears burning, and chest tightness, no breathing difficulty. Patient notified staff and was given O2 and allowed to drink her water. Her symptoms did improve and she was sent to the waiting area again. After about 10 mins her chest tightness came back. Patient states she can feel her blood flowing, "kinda like when your limb is numb". Patient also had symptoms of chills, body shakes, loss of smell, and a metallic taste in mouth. Patient states that she was seen again by staff and laid on a cot for 20 mins, and was then cleared to head back to work around 1000. Patient was seen in the clinic at 1157, and her symptoms since it started have improved. Currently she has the following symptoms: can't taste/smell, (L) arm is sore, H/A, with constant ache, localized to back of neck up to behind the both eyes. Body feels worn out, everything feels heavy, takes a few second to focus when she looks around "like there is a delay". Patient was sent home to recover and to let medical staff know if her symptoms return.
34 2021-01-12 tingling Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "... Read more
Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "cotton ball" in back of throat, dry mouth; administered Epinephrine 0.3 mg IM x3, solumedrol 125 mg, diphenydramine IV 50 mg and 25 mg, famotidine 20 mg, racemic epi, ativan; reaction started 5 min after dose; discharged with epi pen and prednisone
34 2021-01-12 dizziness Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without... Read more
Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without fever 2am-6am fever, chills with rigors at time, nausea, headache, joint pain, fatigue, dizziness, double vision, drenching night sweats 6am-11pm continuing mild fevers and chills without rigors , joint pain, nausea, headache. Last fever was approx 6pm that day but the chills continued 1/13/21 12am-6am chills and fatigue. No fevers. Drenching night sweats 6am- present fatigue and slight headache Motrin was able to help the fevers and I stay well hydrated
34 2021-01-12 dizziness, lightheadedness Pt experienced tachycardia, lightheaded, sweaty, nausea, and near syncope. Pt says she is anxious a... Read more
Pt experienced tachycardia, lightheaded, sweaty, nausea, and near syncope. Pt says she is anxious and feels this was anxiety-related.
34 2021-01-12 pain in extremity Vaccine given on 1/9/21 around 12:45 pm in Left deltoid chest swelling started 5 to 6 hours later sw... Read more
Vaccine given on 1/9/21 around 12:45 pm in Left deltoid chest swelling started 5 to 6 hours later swelling in arm & neck with pain. Has been taken Ibuprofen & muscle relaxer. Symptoms still persistent on 1/12/21.
34 2021-01-12 vertigo Vertigo and headache for 8 days
34 2021-01-12 pain aches, chills, fever
34 2021-01-12 pain in extremity, pain arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted ap... Read more
arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted approximately 2 hours then passed.
34 2021-01-12 pain chills, sweats, nausea and body aches for 24 hours
34 2021-01-12 tingling, dizziness dizziness, tingling in face to neck and nausea; rested and refused emergency department
34 2021-01-13 migraine 1/07@1920 INJECTION RECEIVED 1/8 @ 1100 CHILLS BEGAN @1130 102 FEVER RECORED; 1000MG ACETAM... Read more
1/07@1920 INJECTION RECEIVED 1/8 @ 1100 CHILLS BEGAN @1130 102 FEVER RECORED; 1000MG ACETAMINOPHEN TAKEN @1300 MIGRAIN BEGAN @1700 NAUSEA BEGAN @1900 CHEST PAIN STARTED @2100 WENT TO THE ER
34 2021-01-13 tremor, feeling hot After the vaccine was administered the patient sat in the waiting room for less than 5 minutes and t... Read more
After the vaccine was administered the patient sat in the waiting room for less than 5 minutes and then felt a fast HR, she felt hot and was worried that she was going to faint. She also felt shaking in her hands and her arms felt heavy. She came back to the nurse that had administered her vaccine at 1:10pm where her oxygen level was monitored and she was given a cold cloth and water to drink. This lasted for about 20 minutes. Her oxygen level was monitored (~97%), her BP was checked at 1:45pm and it was 125/90. Her hotness, elevated HR, and shakes went away. At 2:00pm her BP was checked again and it was 139/96 and then again at 2:05pm where it was 132/90. The patient stated that she felt fine and normal by now and also said that she had a BP cuff at work and at home and said that she would monitor it. All 3 of 3 follow up options discussed with patient: virtual care, the CDC, and/or 911 depending on her condition. The patient left at 2:15pm and patient was called 1 hour later for follow up. On the follow-up call the patient stated that she was feeling fine and that her BP was 126/90. She said she would continue to monitor her BP and follow-up with virtual health if it wasn't back to normal by tomorrow.
34 2021-01-13 pain Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. ... Read more
Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. All symptoms subsided within 48 hrs except for the swelling at the injection site.
34 2021-01-13 tremor Flushed, itching, rash over arms, trunk, Felt shaky
34 2021-01-13 pain Headache, fever, chills, nausea, drenching sweat, extreme body aches, fatigue. Swollen clavicle and... Read more
Headache, fever, chills, nausea, drenching sweat, extreme body aches, fatigue. Swollen clavicle and axillary lymph nodes bilateral.
34 2021-01-13 pain, dizziness Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; Th... Read more
Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 07Jan2021 at 10:45 at single dose in left arm for covid-19 immunization. Medical history included allergies to penicillin. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), levothyroxine, desvenlafaxine succinate (PRISTIQ). The patient previously received the first dose bnt162b2 (Batch/lot number: EK5730) on 17Dec2020 at 15:00 in left arm for COVID-19 immunization at age of 33 years old. The patient experienced headache, dizziness, body aches, mild fever, chills, extreme fatigue, and soreness at injection site on 07Jan2021 at 23:00. All events were reported as non-serious by reporter. The patient didn't receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of all the events was resolved in Jan2021. No follow-up attempts are possible. No further information is expected.
34 2021-01-13 lightheadedness, dizziness Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). N... Read more
Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). Near syncope at 0615. Loss of vision, tinnitus, lowered to the ground and followed by nausea and sweating. Resolved in minutes. Continue to be dizzy today with clammy and dizzy upon standing
34 2021-01-13 pain, tremor, feeling cold, pain in extremity I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went... Read more
I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went to bed around 11pm. Then I was woken up in the night around 3am violently shaking, teeth shattering and unable to even stand straight from shaking so bad. I felt like I was freezing but skin was hot to touch. I didn't have a thermometer to take temperature at that time because it was in another family member's room. I felt nauseated as well. I took 600mg ibuprofen and tried to lay back down. At 3:59am my aunt woke and brought the thermometer downstairs. I could tell the ibuprofen was working some and fever was less as the shaking had calmed. I was able to check my temperature and it was 100.8F (an hour after the ibuprofen). I still took 100mg tylenol at that time. As of this morning (after 7am) I am sore all over, tired and have a headache, temp 99.2F.
34 2021-01-13 pain in extremity L arm pain and numbness from injection site to shoulder, temp 99.0-99.5 F
34 2021-01-13 pain Low-grade fever, bodyaches, slight headache
34 2021-01-13 weakness Muscle aches, joint pain, headache, nausea, weakness. Lasted ~24 hours.
34 2021-01-13 bell's palsy, numbness R facial numbness with inability to fully open R eye onset 1/13/21. Seen in urgent care, Dx Bell's P... Read more
R facial numbness with inability to fully open R eye onset 1/13/21. Seen in urgent care, Dx Bell's Palsy, treated with steroids.
34 2021-01-13 tingling, numbness Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.... Read more
Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-13 pain in extremity Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 3... Read more
Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 300 next morning in hot sweat. Next day 1/12, body tension from chills precious night- relieved by advil. fatigue from poor nights sleep.
34 2021-01-13 dizziness Systemic: dizzy, tachycardic (132), bp high 137/88
34 2021-01-13 weakness Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd do... Read more
Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd dose but improving.
34 2021-01-13 tingling, dizziness feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a con... Read more
feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a contactable other hcp. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left hand on 30Dec2020 14:15 at a single dose for COVID-19 immunization. Vaccination occurred in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C), colecalciferol (VITAMIN D), and zinc (ZINC). The patient was feverish, lightheaded, had tingling in fingers and had night sweats on 01Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test-nasal swab with a negative result on 04Jan2021. Information on the lot/batch number has been requested.
34 2021-01-13 pain in extremity left lower leg pain
34 2021-01-14 migraine, pain, dizziness 1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/... Read more
1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/15/21 1/15/21 - 6am -mild headache and body aches, seems to be getting better
34 2021-01-14 pain 101.5 (units not reported) fever; Severe body aches; chills; headache; This is a spontaneous report ... Read more
101.5 (units not reported) fever; Severe body aches; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm from 07Jan2021 to 07Jan2021 at SINGLE DOSE, for covid-19 immunization. The patient 's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for covid-19 immunization on unspecified date (1st dose). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 about 24 hours post vaccine, the patient experienced a 101.5 (units not reported) fever, severe body aches and chills. The outcome of events was unknown. No treatment was required or given due to the events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been requested.
34 2021-01-14 pain, pain in extremity 12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, ru... Read more
12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, runny nose , severe headache, mild palpitations, my whole body hurt. 12/24 I couldn't breathe through my nose at all , no taste or smell for 24 hours, 1 week after I wasn't getting better my lungs sounded junky , 12/31 I went to the urgent care, I got tested and was negative, I had pneumonia , I was sent home with antibiotic, steroids, inhaler.
34 2021-01-14 pain Covid19 second vaccination adverse reaction: Received vaccination at 0815am Tuesday 1/12. By 6pm, on... Read more
Covid19 second vaccination adverse reaction: Received vaccination at 0815am Tuesday 1/12. By 6pm, onset of rigors/chills, body aches, generalized malaise, fatigue, headache which lasted until Wednesday 1/13 ~11:30pm (only x1 low grade fever 99.2 ~6pm Wednesday). Thursday 1/14 called out sick from work residual exhaustion/fatigue and minor headache, body aches dissipated. Able to return to work Friday 1/15.
34 2021-01-14 pain Developed low grade fever (99.3F), fatigue, aches, headache around 6pm on 01/13/2020. Treated with ... Read more
Developed low grade fever (99.3F), fatigue, aches, headache around 6pm on 01/13/2020. Treated with OTC Aleve. All resolved within 12 hours except the fatigue. Also noticed painful axillary lymph node swelling on 01/13/2020 upon waking at 6:30am. Treating with OTC Aleve.
34 2021-01-14 dizziness Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patie... Read more
Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek9231, expiration date was unknown), intramuscularly on the left arm on 08Jan2021 (at 11:00 PM as reported; pending clarification) at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included that the patient had known allergies to medications, food, or other products, but was not specified. Concomitant medications included ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), curcuma longa (TURMERIC) as supplement, and an unspecified multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021 (at 11:15 AM as reported; pending clarification), the patient experienced lightheaded, tachycardia, and blotchy rash, which resulted in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of lightheaded, tachycardia, and blotchy rash, which included diphenhydramine (BENADRYL) and steroid. The patient was recovering from all the events.
34 2021-01-14 tingling, dizziness, numbness Long lasting throbbing headache like non other, nose bleed, numbness on right arm, right shoulder, r... Read more
Long lasting throbbing headache like non other, nose bleed, numbness on right arm, right shoulder, right cheek & face, muscle aches, fatigue, and tingling on forehead. Also felt dizzy.
34 2021-01-14 vertigo, pain, dizziness Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Mus... Read more
Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; This is a spontaneous report from other health professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1686, via an unspecified route of administration from 06Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included Sulfa sensitivity (but allergy not confirmed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, from 18Dec2020 for covid-19 immunization (1st dose). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) and drospirenone, ethinylestradiol (OCELLA), drospirenone, ethinylestradiol (YASMIN). On 06Jan2021 12:00, the patient experienced muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo. The patient underwent lab tests and procedures on 26Aug2020 which included Nasal Swab/ Covid test with negative result; then on 18Dec2020, COVID Antibody Test and COVID Antibody Test both with negative results. The outcome of event was not recovered. No treatment was received/required due to the events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
34 2021-01-14 dizziness Patient received second Pfizer COVID-19 vaccination on 1/7/2021. On 1/8/21 developed nausea, flu-lik... Read more
Patient received second Pfizer COVID-19 vaccination on 1/7/2021. On 1/8/21 developed nausea, flu-like symptoms, dizziness. While walking down stairs became dizzy and fell, injured R shoulder. Presented to urgent care 1/9/21 for shoulder workup, all symptoms of vaccine reaction had resolved. No OTC medications taken for vaccine reaction.
34 2021-01-14 pain Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain, minor nausea, minor headache starting 4 ho... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain, minor nausea, minor headache starting 4 hours after vaccine administration injection site pain, fatigue, worsening headache, body aches (muscle pain), chills, worsening nausea starting approximately 30 hours after vaccine administration
34 2021-01-14 tingling, weakness Reaction started 40min after injection. It started with tingling above the lips and then numbness o... Read more
Reaction started 40min after injection. It started with tingling above the lips and then numbness on the whole face + redness on face and neck per coworker, then collapsed trying to go to the bathroom to look at the redness, then had generalized weakness for about 45 minutes (couldn't move at all or open mouth and eyes). I was finally able to open my eyes 1 hour after it started. Got discharged 2 hours after symptoms resolution. No medication was needed, symptoms gradually faded away.
34 2021-01-14 pain Starting about 12 hours after vaccine I had the expected symptoms of body aches, chills, headache, n... Read more
Starting about 12 hours after vaccine I had the expected symptoms of body aches, chills, headache, nausea and low grade temps. At ~ 0500 on 1/14/21 (~18 hrs after vaccine), I woke up as I was in SVT. I was not able to convert myself and had to go to ED for treatment. HR was 232 upon arrival to ED. Prior to administering adenosine, SVT resolved on own. SVT episode lasted ~2hrs. I have not had a prolonged SVT episode since ablation in 2016. ER doc mentioned that perhaps fever/ illness from vaccine lowered my threshold for going into SVT.
34 2021-01-14 pain in extremity Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired. EE reports woke... Read more
Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired. EE reports woke up Thursday am with fever (Tmax 103) and chills. EE reports temp 99 at time of call. ? Last day of work and shift ? Friday (1/8/21) Home remedies? - Tylenol and motrin q4h, rest Any improvement? ? mild improvement Recommendation? EE encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive and to apply a cold compress to injection site. EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called out of work today. EE educated to manage her RTW according to the Workplace policy. EE said she had a secondary exposure and requested to be tested through hospital but was told by EH unable to test so got COVID tested on Monday 1/11 at pharmacy and reports negative result. EE requesting RN to send her manager and email documenting call. EE notified RN will not be sending her manager an email but if manager needs proof of call, to contact EH. EE verbalized back understanding and denied further questions at this time.
34 2021-01-14 lightheadedness Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness an... Read more
Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness and hard at injection site 2 days late
34 2021-01-14 tremor Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started... Read more
Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started to feel muscle aches and sharp joint pain, as expected. By 1200 noon, the pain intensity was increasing, coming in waves, lasting 10-15 minutes. The pain waves were 10/10, very severe, and was causing me to shake, cry, and be unable to function or sleep. I was also very disoriented, but I think due to the pain. It was mildly relieved with ibuprofen/Tylenol alternating every 3hrs, but continued until 6pm. It began to subside at 6pm. I am an RN, and sought the advice of my employee health nurse, who advised me to seek medical care if it continued through the night. The pain began to subside, so I did not. However, if a non-healthcare person experiences that, they will think they are dying.
34 2021-01-14 dizziness Very fatigued; Slight headache; Dizziness
34 2021-01-14 pain approximately 3 hours after 2nd dose of vaccine developed body aches, chills, malaise. Next day the... Read more
approximately 3 hours after 2nd dose of vaccine developed body aches, chills, malaise. Next day these symptoms persisted and also developed nausea/stomach ache and mild tachycardia. Chills, injection site pain, malaise
34 2021-01-14 dizziness light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushe... Read more
light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushed; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on 22Dec2020 at 11:30 at a single dose on the left arm for COVID-19 immunization in a workplace clinic. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 at 15:00, the patient was light headed (airy/helium head feeling), hard to concentrate on more than one task at a time, and flushed. No treatment was given to the patient. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious. No follow-up attempts are possible. No further information is expected.
34 2021-01-14 vertigo, pain in extremity, numbness, lightheadedness tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My ... Read more
tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-15 migraine, numbness I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14... Read more
I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14, 2021 in my right arm. Almost immediately, I felt a pain go down to my wrist and across my chest. We pulled into the waiting area and around five minutes after the injection the right side of my face went numb., the pain had left my arm and chest by the time. The nurse reacted by calling the emergency room and sending me there.
34 2021-01-15 numbness Left arm went completely numb. Left side of neck was completely numb and left side of face was compl... Read more
Left arm went completely numb. Left side of neck was completely numb and left side of face was completely numb. Duration was for about 3 hours.
34 2021-01-15 feeling hot Observed pt with symptoms of flushing, feeling hot, tingling feeling, felt like her HR was faster. ... Read more
Observed pt with symptoms of flushing, feeling hot, tingling feeling, felt like her HR was faster. Water, Observed for a total of 45 min. Felt the same but was okay. No worsening. Pulse Ox 97%, HR 77 .
34 2021-01-15 weakness Tiredness, Weakness, Sleepiness.
34 2021-01-16 pain in extremity, restlessness, pain I woke up around 11:30p (1/15) with aching in my legs. I took some Tylenol a d laid back down. I bec... Read more
I woke up around 11:30p (1/15) with aching in my legs. I took some Tylenol a d laid back down. I became restless and tossed and turned. My body started aching and by morning (7a 1/16) I had a blinding headaches, body and joint pain and a fever of 101.8. This continued throughout the day 1/16. I also had chills. My fever broke around 2am 1/17 and the body aches went away. I have had a headache and fatigue today (1/17).
34 2021-01-16 pain in extremity, pain I woke up with pain in my legs, took a bath & some ibuprofen. Laid back down and just tossed and tur... Read more
I woke up with pain in my legs, took a bath & some ibuprofen. Laid back down and just tossed and turned for a few hours. When it was time to get up with my kids my whole body hurt. I took my temperature and it was 102.4. I took some Tylenol and drank water. I stayed in bed for the day. I ran a fever until late that night. (12/24) When I awoke 12/25 I did not have body aches only a headache and fatigue. By 12/26 I felt better.
34 2021-01-16 pain Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my... Read more
Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my arm. By 7 pm my left arm felt sore. By 8 pm I began to have chills, my temp was 98.1 and I had muscle aches. By 10 pm I had a fever of 101.5, chills, muscle weakness, aches, and a headache.
34 2021-01-16 tingling Tingling lips, hands and feet for an hour after vaccine shot. It did not start right away, but short... Read more
Tingling lips, hands and feet for an hour after vaccine shot. It did not start right away, but shortly after I left Vaccination site. After about an hour my lips were tingly for the rest of the day until halfway through the next day. I still feel little twinges of tingling in my lips here and there. The sensation does not last long about a minute and goes away.
34 2021-01-17 weakness generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan20... Read more
generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan2021; This is a spontaneous report from a contactable pharmacist. A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular in left arm on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic HTN and allergies to baclofen and statins. The patient's concomitant medications were unspecified medications taken for hypertension. The patient previously received the first dose of bnt162b2 on 19Dec2020 via intramuscular in left arm, lot EL0140. On 08Jan2021, the patient was brought into ER as code MET. Patient was receiving her second vaccine for COVID-19 when she experienced generalized weakness and flushing. She stated that she knew her BP was high. Endorses hx chronic HTN, reports she took all three medications this AM. The patient denied any headache, new visual change, CP, SOB, or focal weakness. The events recovered on an unknown date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.; Sender's Comments: Based on the time association, the events asthenia, flushing and hypertension are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-18 vertigo, pain, restlessness, feeling cold 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nau... Read more
9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
34 2021-01-18 weakness, dizziness, tremor, pain Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to h... Read more
Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to have some chest pain. Felt as if I was intoxicated, lasted the whole day. Woke up the next morning and still felt "out of it" and weak but thought it would get better, went to work (im a nurse). Started having continous vomiting, shortness of breath and chest pain at work. As well as severe tremors. I was taken to the hospital, given fluids and my QT was prolonged with my heart which i have never had before . Was given iv magnesium and waited for my heart rhythm to improve. Was told not to take anymore of my prescribed medications or nausea medications and follow up with my pcp the next day. Im still feeling horrible, nausea, body aches, low grade fever and I am 72 hours out. Now I have huge hospital bill to pay, can't work currently because I still feel bad and my heart has a weird rhythm. Hoping this helps as if this was what I was expecting I would have never got it.
34 2021-01-18 pain Woke up feeling achy, chills, Feverish Low grade fever Estimated date of delivery 08/25/2021
34 2021-01-19 dizziness, pain After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After... Read more
After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication included vitamin c [ascorbic acid]. The patient previously took Benzoyl peroxide and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) intramuscular (right arm) first dose on 18Dec2020 for Covid-19 immunization and experienced flu like symptoms for 48 hours plus bilateral cheek numbness for two weeks. On 08Jan2021, after the second dose the patient experienced myalgia body ache fever axillary lymph node swelling and pain dizziness nausea. This was day 4 post vaccine, still have severe dizziness and fatigue. On 04Jan2021, the patient underwent lab tests and procedure which includes Coronavir Pan 2019-NCOV, NAA with the result of Negative and Nasal Swab with the result of Negative. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination.
34 2021-01-19 dizziness, pain Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of ... Read more
Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of vaccination given at 11 am 1/14/2021. Pain at the injection site . Then body ache started. Midnight 1/14/2021 - chills started, fever 103, severe headache- Fever, body ache and headache continued till Monday(1/18/2021) Strong Metallic taste in the mouth, nausea, dizziness- still continuing.
34 2021-01-19 weakness, pain HEADACHE, BODYACHES, WEAK
34 2021-01-19 feeling cold High fever, muscle pain, joint pain, headache, chills, swollen Lymph nodes in the arm of injection (... Read more
High fever, muscle pain, joint pain, headache, chills, swollen Lymph nodes in the arm of injection (armpit)
34 2021-01-19 pain I experienced extreme body aches that were so bad I was unable to perform daily tasks. I also had fe... Read more
I experienced extreme body aches that were so bad I was unable to perform daily tasks. I also had fever, chills and fatigue as well as nausea.
34 2021-01-19 pain I had one day of sweats, body aches, and fatigue in which I stayed in bed the calendar day after I g... Read more
I had one day of sweats, body aches, and fatigue in which I stayed in bed the calendar day after I got the second vaccine. I planned to get the vaccine on a Friday when I was off the following day in case this happened so I could rest, but if I had been scheduled to work I would have taken the day off to rest based on the symptoms. I felt normal the next calendar day. I was 31 weeks pregnant at the time, had no adverse events related to the pregnancy, and am due 3/10/21 with a delivery scheduled 3/3/21; baby and mom are doing just fine.
34 2021-01-19 pain Patient presented to urgent care on 1/17/2021 after receiving second dose of Pfizer COVID-19 vaccine... Read more
Patient presented to urgent care on 1/17/2021 after receiving second dose of Pfizer COVID-19 vaccine on 1/14/2021. Patient stated that she had a sore throat and was fatigued X 3 days. Patient endorsed body aches and nausea immediately after vaccination. Patient had expiratory wheezing in left upper lung and has a history of asthma. Patient endorsed increased inhaler use over the past few days. Patient was given outpatient rx for prednisone and viscous lidocaine.
34 2021-01-19 pain Severe chills that last hours, fever of 101.1, full body aches, sore throat, exhaustion.
34 2021-01-19 numbness Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tyl... Read more
Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tylenol and a nap. Around 1100-1130, I started to feel a little feverish, but did not have a fever. Around 1200, I began to have chills, my headache returned, and my fingers and toes felt frozen/numb. I took a very hot bath for approximately 45 minutes and subsequently laid in the bed (with intermittent napping) for 2 hours. Upon full wake up around 1430, I had no more chills, no headache, and felt back to my normal self.
34 2021-01-19 dizziness Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This... Read more
Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 18Dec2020 08:15 AM as a single dose for COVID-19 immunization, lot number: EL0140. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications in two weeks prior to the vaccination included Multivitamins, Vitamin C, Vitamin D3, zinc oxide and fluticasone propionate (FLONASE). On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. No treatment was received for the events. Patient recovered from all the events on unknown date in Jan2021. Patient had not been tested for COVID-19 post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015086 same patient/vaccine, different dose/event
34 2021-01-19 tingling TINGLING ARM ; RESOLVED
34 2021-01-19 vertigo Tinnitus, hearing loss in left ear started on 12/31/2020 and has not resolved. Vertigo and vomiting... Read more
Tinnitus, hearing loss in left ear started on 12/31/2020 and has not resolved. Vertigo and vomiting started on 1/12/2020 with a duration of approximately 48 hours then resolved.
34 2021-01-19 pain Vaccine was administered very high, presumably in the joint space, rather than the deltoid. Patient ... Read more
Vaccine was administered very high, presumably in the joint space, rather than the deltoid. Patient experienced intense pain in the entire shoulder area for 24 hours following administration. After initial 24 hours, pain remained more localized in the joint itself. Pain is intensified when moving out of the neutral position.
34 2021-01-19 pain fever, chills, aches
34 2021-01-19 pain hand swelling headache body pain general GI upset
34 2021-01-19 pain ~ 6 hrs after vaccination, headache started ~18 hrs after vaccination, still had headache and also f... Read more
~ 6 hrs after vaccination, headache started ~18 hrs after vaccination, still had headache and also felt malaise ~24 hrs after vaccination, still had headache and malaise, and started feeling total body aches/soreness ~36 hrs after vaccination, all other symptoms resolved but now had swollen and tender lymph node under R arm. Approaching 48 hrs from vaccination and the swollen lymph node has not resolved. Of note - I am currently breastfeeding. I did not have any decrease in my breastmilk supply and noted no changes in my infant either.
34 2021-01-21 dizziness ? Chills (from 12 hours after the shot until present?33 hours so far) ? Slight fever (under 100) ? H... Read more
? Chills (from 12 hours after the shot until present?33 hours so far) ? Slight fever (under 100) ? Headache ? Nausea & vomiting ? Dizziness ? Insomnia
34 2021-01-21 feeling hot, dizziness About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed ... Read more
About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed to sit down. Never lost consciousness and was able to able to breath through the event and drink water after a couple of minutes. Patient also felt rapidly hot and dizzy. We had her sit down, take deep breaths, kept her talking, offered water, and got epinephrine ready. She recovered completely after a total of 30 minutes but did feel slightly dizzy throughout the day. Was able to continue with regular workday as we determined it was best she stayed with other people for the remainder of the day.
34 2021-01-21 weakness, pain, dizziness Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe b... Read more
Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe body pain, and dizziness. Felt like she was going to pass out in the bathroom so she called her husband to assist her. Stayed 1 day in bed. Didn't received treatment.
34 2021-01-21 pain Fever, muscle/body aches, headache, fatigue
34 2021-01-21 tingling, numbness, dizziness, feeling hot Immediately afterwards developed L-sided facial weakness/numbness, stiff neck, BUE/BLE paresthesia, ... Read more
Immediately afterwards developed L-sided facial weakness/numbness, stiff neck, BUE/BLE paresthesia, sensation of feeling hot (T 99 F). Was observed for 2 hours, given Benadryl. No longer feeling paresthesia or hot, but still has mild L-sided facial weakness, stiff neck, and in past 2-3 days having dizziness upon awakening, resolves after a few minutes. No dysphagia. Never had facial droop. BP 119/80. Spoke w/physician 2 days ago about her symptoms and was reassured they're due to vaccine.
34 2021-01-21 swollen extremities, pain, dizziness, feeling hot The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird... Read more
The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird" in my whole body and lightheaded. I got some juice. Then I started to get hot and was sweating, my whole face and neck were flushed; I also felt mild burning sensation on the R lower lung area. They took me in back and gave me more juice and water and put ice packs on me. It took 30+ minutes to feel better. They called a team to come do my vitals and my HR was in the 100s and they said my eyes were dilated. On my way home I had a weird throbbing pain in my L upper chest just above my boob. When I got home I had chills/felt freezing for a few hours and was fatigued. The next day (Sun) I had moderate joint pain, fatigue, and was very achy; my chest felt tight and I needed my inhaler and some tramadol. On Mon I felt better and went back to work, but then Tues I was achy again and my coworker said I looked pale; I took some tramadol and felt better, just tired. On wed I was having pains in my neck, shoulder, down my arm L arm, and down my scapula- the arm I had the injection. Throughout the day the pain was throbbing and ended up a 7/10 and edema in my neck/shoulder/axillary occurred; I couldnt carry anything heavy and was guarding that arm. Tramadol didn't help the pain and I eventually took 600mg ibuprofen and made a telemedicine visit w/ my MD for the next day. After 3 days the pain was subsiding but the edema took ~ 1 week- it subsided the weekend before my next vaccine. The day of my 2nd dose I did ok after the vaccine at 4pm. While they were injecting it I felt burning down my arm. I felt lightheaded and "weird" afterwards and warm, but no eye dilation or flushing. 3 hours after the vaccine at 7pm I felt tired and a little achy and slept from 7-9pm. At 9pm I woke up very achy, I had 1 itchy hive that popped up on my R inner forearm. The next day I had joint pain in every joint and very achy and fatigued. The joint pain subsided on day 2 after the vaccine but I was very achy and fatigued for a good 72 hrs. Vaccine was wed and saturday the pain in my neck returned and the edema came back and was a little worse than before, and the area where the edema was, was painful to touch. It started subsiding ~ a week after the vaccine, but a little bit is still currently here- but no pain to touch. My allergist has been following up w/ me this whole time.
34 2021-01-24 pain I got my vaccine around noon on 1/23 and woke up 1/24 with chills, body aches, and was fatigued. I t... Read more
I got my vaccine around noon on 1/23 and woke up 1/24 with chills, body aches, and was fatigued. I took ibuprofen- 2 separate doses that day- which helped. I felt that all these symptoms had completely resolved by about 7pm on 1/24.
34 2021-01-24 facial paralysis, tingling On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I w... Read more
On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I was slowly throughout the day unable to drink out of a cup without dribbling, my right eye was constantly watering, around 4pm: my right arm started tingling and bothering me, around 9pm: I tasted a Novocain(numbing) like taste in my mouth, I showered and went to bed, while in bed around 10:30pm: I drank out of a water cup and immediately drooled water onto my shirt and my right arm was starting to tingle even more, I thought that was out of the ordinary and got up to look in the mirror, when I looked in the mirror, my first thought was to smile and the right side of my mouth drooped, my right eye was drooping and I was unable to smile or close my eye. At 12:30: I went to the ER for tingling on my face and right arm, I thought I was having a stroke. In between home and traveling to the ER, paralysis started on my right side of face
34 2021-01-25 tingling, numbness About 15 min I felt numbness and tingling on my face. Gradually felt it in my whole body by 8:30PM ... Read more
About 15 min I felt numbness and tingling on my face. Gradually felt it in my whole body by 8:30PM that night, next day I tried to go to work but I had to leave because of the intense numbness and tingling. I also developed left leg weakness and had to even pick up my leg to be able to walk. The NP at my neurologist office (talked over the phone) said it was a pseudo effect due to my MS. My symptoms are still intermittent up to my second dose. It is all over the numbness and tingling, but as it is subsiding it is now flaring up my symptoms from 2 years ago and I feel it on my second side.
34 2021-01-25 pain Body aches, joint pain, chills without fever, headache, nausea, fatigue
34 2021-01-25 tingling Chest pain, High blood pressure, Heart rate was fast and i also had tingley hands . It happened abo... Read more
Chest pain, High blood pressure, Heart rate was fast and i also had tingley hands . It happened about 45 Minutes after i had the vaccine. I was then sent out to the hospital.
34 2021-01-25 pain HA, fever = 101, body aches.
34 2021-01-25 dizziness Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever... Read more
Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever; chills; tachycardia; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), intramuscular, on 09Jan2021 10:30 AM, at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gastrooesophageal reflux disease (GERD). She had no allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EJ1685, expiry date: not reported), intramuscular, on 19Dec2020 12:00 PM, at a single dose on right arm for COVID-19 immunization. On 09Jan2021 11:00 AM, the patient experienced headache, nausea, congestion, muscle aches, extreme joint pain, fatigue, dizziness, neck pain, fever, chills and tachycardia. The adverse events resulted to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19; she had undergone Nasal Swab, test name: COVID-19 nasopharyngeal swab, on 11Jan2021 with result of negative. The patient received metoprolol as corrective treatment for the reported adverse events. Outcome of the events was recovering.
34 2021-01-25 dizziness, weakness I experienced weakness, fatigue, lightheadedness for the most of day after receiving the shot. Sympt... Read more
I experienced weakness, fatigue, lightheadedness for the most of day after receiving the shot. Symptoms reduced with rest, plenty of water. Symptoms resolved by morning of 1.26.2021
34 2021-01-25 pain Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x ... Read more
Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x 2 days.
34 2021-01-25 tingling, numbness Soon after receiving the second dose just like the first one I started developing tingling and numbn... Read more
Soon after receiving the second dose just like the first one I started developing tingling and numbness on my face and arms, chest. On Sunday I also started feeling chest tightness so I went to the ER. EKG was normal. They told me to follow up with my neurologist. I still have lingering symptoms of tingling and numbness that come and go.
34 2021-01-25 pain Woke up morning of Monday, January 25,2021 at 230am for work and felt nauseous, had chills and body ... Read more
Woke up morning of Monday, January 25,2021 at 230am for work and felt nauseous, had chills and body aches and hurt to the touch all over. My head felt heavy. I had to leave work early and took off the next day due to not feeling well
34 2021-01-25 tingling, numbness had numbness/to her bottom jaw bone/switched between her cheek and jaw and then her nose; face start... Read more
had numbness/to her bottom jaw bone/switched between her cheek and jaw and then her nose; face started tingling/from her lower eyelid/switched between her cheek and jaw and then her nose; face started tingling and had numbness/from her lower eyelid; face started tingling and had numbness/affects her lips/and mouth sometimes; face started tingling and had numbness/affects her lips/and mouth sometimes; It is just very annoying/It is irritating; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3284), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included ongoing anxiety since she was 13 years old. The patient's concomitant medications were not reported. The patient received the vaccine on Monday at 12 o'clock. She got it for work. She doesn't have a prescribing doctor. She developed the side effect Tuesday at 2 am. The left side of her face started tingling and had numbness, which is the same side she received the vaccine on. She doesn't have weakness. It is not resolving. It is from her lower eyelid to her bottom jaw bone. When asked if it was improving persisting or worsening, she said it depends. Sometimes it gets worse and affects her lips, and sometimes it is on and off. It won't be completely gone. It switched between her cheek and jaw and then her nose and mouth sometimes. If she bends over, it tingles worse. It is just very annoying. It felt like if she had Novocain on the top and bottom of her mouth. It is irritating. She got it because she doesn't want COVID and she works as a nurse. She does have really bad anxiety. She has nothing else medical. She is just really nervous. It is not going away. She is freaking out. She would like more information. The outcome of the event "It is just very annoying/It is irritating" was unknown, while for the other events was not recovered.
34 2021-01-26 pain in extremity 25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low ... Read more
25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low back, hips, legs achy, runny nose, HA 27th January-SAME-nose stopped running, increased fatigue, site of injection-more red/swollen, rt armpit-achy & swollen Treatment-she said she took an aleve this AM-27th Jan, and she will get some PEDILYTE today to sip
34 2021-01-26 pain Diarrhea, Nausea, Headache, Fatigue, Body Aches started at 4am Tuesday 1/26 and still ongoing today ... Read more
Diarrhea, Nausea, Headache, Fatigue, Body Aches started at 4am Tuesday 1/26 and still ongoing today presently. Cough is starting today.
34 2021-01-26 pain Patient with underlying MS and pregnancy. Patient reported that Fever, body aches, chills, fatigue ... Read more
Patient with underlying MS and pregnancy. Patient reported that Fever, body aches, chills, fatigue after administration of 2nd dose. Presented to the Emergency Department / OB triage in labor 4 days later (1.24.21) Patient is a 34 y.o. female at 37w0d with Estimated Date of Delivery: 2/14/21 who presents today with spontaneous labor. HOSPITAL COURSE: Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition. ESTIMATED DUE DATE: Estimated Date of Delivery: 2/14/21 GESTATIONAL AGE AT DELIVERY: 37w0d. Patient weight = 2.63 KG
34 2021-01-26 tingling Vaccine administered. Patient reported L upper arm paresthesias ~7 min after administration. States ... Read more
Vaccine administered. Patient reported L upper arm paresthesias ~7 min after administration. States she had the same reaction with first dose that self resolved by end of day. Patient was monitored for 30 minutes with improvement of symptoms and no development of new or worsening symptoms. Patient was advised to seek ER eval if she develops any throat itching or tightness, tongue swelling, shortness of breath or vomiting.
34 2021-01-27 pain High fever. Aches chills. Sob. 4 days. Passed on 1/27/2021
34 2021-01-27 dizziness On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The nex... Read more
On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The next day I woke up with an intermittent headache, little bit fatigue, very very tired, my arm was super heavy and I was in bed all day. The third day I felt dizzy at times, tired, my eyes itched a lot and my body. I didn't take any medication at any time.
34 2021-01-28 numbness, pain, weakness 1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating... Read more
1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating to right side and right lower quadrant without any known injury. Presented to ER on 1/11/21 and was found to have elevated liver enzymes. 1/12/21 woke up with right thigh numbness and was referred to spine specialist by PCP. Saw spine specialist on 1/14/21 and was referred to physical therapy and given medrol dose pack taper. Repeated liver enzymes after 1 week resulted with abnormal results and referred to GI doctor. 1/28/21 Developed worsening right thigh numbness with decreased strength to right leg and following up with spine specialist on 02/01/21.
34 2021-01-28 pain 12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body so... Read more
12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body soreness, tired, nauseous, pain at injection site, headache. Took 1000 mg Tylenol at 11 am and 7 pm. Day 2 Body aches, tired. Currently 12 weeks pregnant as of 2nd dose date.
34 2021-01-28 pain in extremity, pain Evening of 1/25/2021 she experienced a sore arm and toss and turned through out hours of sleep. Repo... Read more
Evening of 1/25/2021 she experienced a sore arm and toss and turned through out hours of sleep. Reports significant s/sx onset this morning arounf 0100, 1/26/2021 to include chest tightness with a sharp pain when inhaling, all over body aches, chills, fatigue and sore arm. Employee states about 1 hr. post vaccination she tasted blood in her mouth and noticed when she . States supervisor referred to OH to be evaluated. Employee also reports hx. of COVID illness with a positive result on 12/27/2021. States onset of s/sx was on 12/26/2021. Patient reported to employee health clinic to report adverse event. On, 1/27/2021 patient was seen by her PCP for evaluation.
34 2021-01-28 pain in extremity Fatigue, arm pain, contractions (baby due date 7/30/2021)
34 2021-01-28 pain Fever up to 104, body aches, chills, headaches Tylenol and Motrin alternated every 5 hours Symptoms ... Read more
Fever up to 104, body aches, chills, headaches Tylenol and Motrin alternated every 5 hours Symptoms started on Wednesday 1/27/21 @ 2am and finished on Thursday morning 1/29/2021
34 2021-01-28 pain, migraine Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. W... Read more
Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. Within the first 15 hours following the injection I began experiencing extreme full body pain, neck, back, arms, legs, hands, and fingers. As well as experiencing a major headache equivalent to migraine pain. The pain was intense and lasted around 36 hours. Pain had subsided within 48 hours excluding pain at injection site that continued but was significantly milder.
34 2021-01-28 pain Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I ... Read more
Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I started experiencing injection arm soreness around 2100. By midnight I was experiencing chills and body aches. The morning of 1/27 my Temp was 100.0 and I was still having body aches and chills/feeling feverish. This continued throughout the day. I took one dose of Tylenol 1g and later ibuprofen 600mg. The morning of 1/28 I still had a mild headache and temp of 100.00 but overall was feeling much better - no more chills or body aches. My temp prior to going to work that night was 98.6 and my headache had resolved.
34 2021-01-28 pain in extremity, pain Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed... Read more
Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed low grade temp, flushed face, fatigue, muscle stiffness, body aches hours following vaccine. Aches and fatigue continues and it?s now day 8. The fatigue is constant but comes in waves. I?m taking unexpected naps which are abnormal for me. Caffeine and methylphenidate are ineffective. I?m still sore. I also have brain fog, maybe from the fatigue. I can?t think straight and it takes me longer to process and do tasks. I woke up 2 hours ago and I can?t wait to sleep again.
34 2021-01-28 tingling Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable ... Read more
Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3248), via an unspecified route of administration at site of left arm at 13:15 on 15Jan2021 at single dose for COVID-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), obesity and known allergies: Sulfa. Concomitant medication included cannabidiol (CBD OIL) and paracetamol (TYLENOL), both received within two weeks of vaccination. The patient experienced tight/sore jaw and tingling in cheeks, both at 13:30 on 15Jan2021. The patient was not pregnant at time of vaccination. Facility type vaccine was in workplace clinic. No other vaccine in four weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovering.
34 2021-01-28 tingling, dizziness light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a cont... Read more
light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El0142), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (COVID-19 antibody test with positive result) and allergies; Iodine. Concomitant medication included vitamin c [ascorbic acid] and calcium. Both received within two weeks if vaccination. The patient experienced lightheaded, tingling of body and face and rash on right arm on 17Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No treatment received for adverse event. No covid tested post vaccination. The outcome of events was recovering.
34 2021-01-31 pain I became very tired almost immediately after my second dose, and proceeded to take a 3 hour nap. Upo... Read more
I became very tired almost immediately after my second dose, and proceeded to take a 3 hour nap. Upon waking up from the nap, I had full body aches, joint pain, a headache, and a low grade fever. Said symptoms have now lasted over 24- hours
34 2021-02-08 pain Abdominal pain that began at center of abdomen upon waking up at 8 am on 2/7/2021 and progressively ... Read more
Abdominal pain that began at center of abdomen upon waking up at 8 am on 2/7/2021 and progressively got worse throughout the day . Developed nausea and multiple episodes of vomiting around 3 pm. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement. Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Imaging and labs could not confirm diagnosis but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis.
34 2021-02-10 feeling cold Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous r... Read more
Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ3247), via an unspecified route of administration in the left arm on 23Jan2021 at 15:20 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included gestational diabetes (first pregnancy) from an unknown date to an unknown date and two pregnancies on unknown dates. Concomitant medications included unspecified post-natal multivitamins and paracetamol (TYLENOL; Lot Number: SBA22; Expiration Date: Jan2023) taken before getting the vaccine on 23Jan2021 to prevent soreness. The patient previously received the first dose of BNT162B2 on 03Jan2021 (at the age of 34-years-old; Lot Number: EL0142) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 24Jan2021 at 04:00, the patient experienced chills and had a feeling like a heavy weight on her body. On 24Jan2021 at 07:00, the patient had a fever and headache. On 24Jan2021, she also had back pain. The clinical course was as follows: On 23Jan2021, the patient took paracetamol before getting the vaccine as she heard one can feel sore after getting it. The patient received the second dose on 23Jan2021 at 15:20. The patient was okay after she got the vaccine. However, early the next morning (24Jan2021), she had shivering without any fever (later referred to as chills). The chills were something she never experienced in her life. It was like she was in the cold. She could not move, it was that bad. She felt a heavy weight on her whole body. She could not get out of bed. A few hours later at 07:00, she checked her temperature and it was 102.5 degrees Fahrenheit. She took paracetamol. The headache started with the fever around 07:00. She stated she kept taking paracetamol. She did try to stop using paracetamol, but without it, the headache was still there. The back pain was also severe on 25Jan2021. The chills recovered on 25Jan2021 and the fever was recovered on 26Jan2021. The clinical outcomes of the headache and felt like a heavy weight on the body were unknown; while that of the back pain was not recovered. The events of chills, fever, headache, and back pain were reported as serious by the patient (nurse) for being medically significant. The patient (nurse) assessed the events of chills, fever, headache, back pain, and felt like a heavy weight on her body were related to the vaccine.; Sender's Comments: Based on a compatible temporal association and known BNT162B2 vaccine safety profile causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-02-10 migraine, pain, facial paralysis right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of h... Read more
right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of facial paralysis due to temporal relationship and current drug safety profile. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-02-16 dizziness shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous ... Read more
shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 29Jan2021 14:30 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: sulfa, and peanuts. Concomitant medication included prednisone. The patient previously took iodine and experienced allergy, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 08Jan2021 15:30 in left arm, at single dose for covid-19 immunization and experienced facial swelling within a couple hours of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose within 30 minutes, 29Jan2021 15:00, the patient had Increased HR over 120 bpm, shortness of breath, dizziness and throat tightening, which all caused hospitalized and Emergency room. Epinephrine injection, fluid, and rest was received as treatment. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Amendment: This follow-up report is being submitted to amend previous reported information: historical vaccine information was added.; Sender's Comments: Based on the compatible time association, the events shortness of breath, dizziness ,throat tightening and heart rate increased are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-02-21 tingling, numbness Face became tingly and numb - lasted about 10 minutes Later that night I also experienced tingling a... Read more
Face became tingly and numb - lasted about 10 minutes Later that night I also experienced tingling and numbness and heaviness of the left side of my body (specifically arm and leg) on the affected/vaccinated side, drouth, and sleeplessness for about 2 hours
34 2021-02-21 pain The next day on 1/15/2021 around noon I felt achy, fatigue, muscle aches, headaches, & feverish. The... Read more
The next day on 1/15/2021 around noon I felt achy, fatigue, muscle aches, headaches, & feverish. They went from mild to sever as the day continued. This symptoms stayed severed for the next 12hrs then they went mild for the next 3 days.
34 2021-02-22 dizziness Began feeling short of breath and dizzy. Was given 25mg Benadryl PO and symptoms resolved
34 2021-02-22 dizziness Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizzin... Read more
Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizziness, cannot exercise
34 2021-02-22 migraine, pain I started experiencing high fever, (103) body aches, muscles, nauseated, diarrhea, and migraine.
34 2021-02-22 pain I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 ... Read more
I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 degree. Then 14 hours later I had chills and aches. Then I woke up with night sweats that drenched my sheets and clothes. Then I had a stabbing pain in my chest on the left side.
34 2021-02-22 pain Joint pain, muscle soreness, body aches lasting 48+ hours so far
34 2021-02-22 tingling, numbness Numbness and tingling of face and lips that got progressively worse. Throat swelling
34 2021-02-23 difficulty speaking SOB, Hives, Reddness, Swelling in throat and lips. hoarseness and wheezing
34 2021-02-24 pain Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare profes... Read more
Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8983) intramuscular on the left arm on 27Jan2021 08:30 at a single dose for Covid-19 immunization. Medical history included allergies, sinus (disorder), hearing loss and allergies: shellfish and sulfa. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (first dose, 04:00 PM Intramuscular on the left arm lot number: EL 0142). Concomitant medication included nigella sativa (black seed oil), turmeric [curcuma longa rhizome] and multivitamins. On 28Jan2021 05:00 AM, the patient experienced fever, headache and body aches. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
34 2021-02-28 pain in extremity Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professi... Read more
Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on 19Dec2020 08:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced sore arm, mild headache, and nausea after the first dose on an unspecified date with outcome of not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
34 2021-02-28 pain intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report... Read more
intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 19Dec2020 at 08:45 AM on right arm (lot number: EH9899) for COVID-19 immunization and experienced sore arm, mild headache/nausea. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jan2021 20:00, the patient experienced intense body aches, fever, joint pain; and approximately 1 week after through more than 2 weeks after (Jan2021) had several episodes of tachycardia. No treatment was received for the adverse events. The patient has not recovered from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
34 2021-03-01 pain On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.... Read more
On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.8 and saw an Urgent Care provider who referred me to the hospital. Upon arrival my fever spiked to 102.3, bloodwork showed elevated lactate at 2.4 and pulse rate was over 119. I was admitted with sepsis symptomatology.
34 2021-03-02 dizziness, weakness Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle c... Read more
Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-03-02 pain Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself o... Read more
Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself out of bed; extremely achy body to the point where it was difficult to lift myself out of bed; I also had extreme fatigue; I slept for almost 20 hours straight, and slept through work without waking up to call out; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1238), intramuscular from 28Jan2021 15:45 (03:45 PM), (at the age of 34-years-old) at single dose on left arm for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included bipolar 2 disorder (reported as "ipolar 2 disorder") and attention deficit hyperactivity disorder (ADHD). Patient has no allergies to medications, food and other products. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (100 mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL; reported as "Adderall XR 15 mg") and quetiapine fumarate (50 mg). Patient did not received any other vaccines within 4 weeks prior vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient received first dose of COVID-19 vaccine on 07Jan2021 01:00 PM (lot number: EH9899), intramuscular on the left arm. On 29Jan2021 02:00 AM, the patient experienced fever, chills, cold sweats, extremely achy body to the point where it was difficult to lift herself out of bed. The patient also had extreme fatigue. Patient slept for almost 20 hours straight, and slept through work without waking up to call out. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovered in 2021. Body temperature on 29Jan2021 with unknown results. Since the vaccination, the patient has not been tested for COVID-19
34 2021-03-02 tingling, numbness left arm completely numb; tingling; This is a spontaneous report from a contactable other health pro... Read more
left arm completely numb; tingling; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL1284 and expiry date unknown, via unspecified route of administration at the left arm on 30Dec2020 12:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sinusitis, placenta precreta, infertility, C-section, sulfa allergy, seasonal allergy. The patient's concomitant medications were not reported. The patient previously took hydrocodone, coriander oil; both experienced allergies. The patient had no other vaccine in four weeks. On 31Dec2020 06:00, the patient experienced left arm completely numb and tingling for 4 weeks. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment due to the events. The patient underwent lab tests and procedures which included nasal swab (Covid-19): negative on 26Jan2021. The outcome of the events was recovering.
34 2021-03-10 seizure Seizures starting 1/25/21, transverse myelitis diagnosed 3/1/21 with symptoms of transverse myelitis... Read more
Seizures starting 1/25/21, transverse myelitis diagnosed 3/1/21 with symptoms of transverse myelitis starting 2/5/21. Now with diagnosis of multiple sclerosis but with atypical initial presentation
34 2021-03-11 pain in extremity, dizziness, pain dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); fa... Read more
dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); faint; body aches; headache; her arm hurt; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's vaccine on Thursday, morning (11Feb2021), at the time her arm hurt. She had body aches the entire Friday (12Feb2021) and headache; she stayed in bed all day and the next day, she took Tylenol. On Saturday (13Feb2021), she had shortness of breath and the urge to vomit (nausea), she was about to faint. She was also dizzy and checked her blood pressure, it was "high", around 129/88, but she can't recall the values exactly. She doesn't know if she should get the second dose because she's scared. The patient wanted to know if these are symptoms from the vaccine or could it have been a reaction or allergy. She is scheduled for the second dose on 04Mar2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
34 2021-03-14 numbness, tingling Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-... Read more
Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot En5318), via an unspecified route of administration, on 05Feb2021 at 01:30 PM (at the age of 34-years-old) as a single dose for COVID-19 immunization, in left arm. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 at 10.45 (lot EL1484, expiry 30Apr2021), for COVID-19 immunization and experienced the onset of headache, intense arm pain at the injection site and mild joint pain. The patient's concomitant medications included The medical history included: Asthma, GERD, and obesity. Allergy to Sulfa. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 (lot E63248), for COVID-19 immunization in left arm. The patient's concomitant medications included ALBUTEROL [SALBUTAMOL]. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 13:45, she reported experiencing Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back. Patient received treatment of 3 doses of Benadryl. The outcome of the events Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
35 2020-12-31 feeling of body temperature change, seizure After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and... Read more
After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and felt like passing out. I got transferred to the er where I received the epipen along with oxygen and antiseizure meds for my seizure. I was then transferred to Medical Center for further care where I was later discharged.
35 2020-12-31 dizziness Dizziness, chills, fever, muscle aches, pain at the injection site
35 2020-12-31 feeling cold, tingling, numbness No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills w... Read more
No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills which I read is normal but I noticed tingling in my legs. And a cold sensation. No weakness and it resolved in about an hour. Then today 1/1/2021 numbness and tingling/pins and needles in my feet and legs . It lasted a few hours and mostly resolved. I was not sure if there was a possibility of guillian barre occurring post this .
35 2020-12-31 tingling, numbness Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, th... Read more
Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, this seemed to subside. Tiredness has appeared to come and go over the last few days. Every morning I have woken up with tingling in my left hand, as though there are pins and needles in my left hand. My left arm feels weaker and feels some numbness when more pressure is placed on it. I have a bruise that appeared above my left wrist. I have reached out, as this is my employer and I have not heard back. Assuming they were closed due to New Year?s Day.
35 2021-01-01 pain in extremity On December 31, 2020 at around 530PM I felt a discomfort on my left jaw that lasted for couple hours... Read more
On December 31, 2020 at around 530PM I felt a discomfort on my left jaw that lasted for couple hours, and at around 9PM I felt a stabbing pain on my whole left arm, I took Acetaminophen 500 mg 2 tabs without relief. The pain lasted 'til dawn, fell asleep and woke up and pain was gone.
35 2021-01-02 pain, feeling cold, pain in extremity, numbness 12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in ... Read more
12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in my left hand, within 30 minutes my left ear felt like it needed to pop, I had the normal/expected side effects for the first 1-2 days (very sore arm, headache, achy, fatigue, mild joint pain) 12/24/20: weakness/numbness/cold feeling in my left lower leg and foot, fullness in left ear continued 12/27/20: same sx as 12/24, plus weakness/numbness in left forearm, pinky and ring finger 12/28/20: same sx as above, plus fullness in R earned weakness/numbness in right forearm, pinky, and ring finger 12/30/20: same sx as above, plus weakness/numbness on the left side of my face, no drooping 12/31/20: same sx as above, now with weakness/numbness/cold sensations on both sides of face (although only one side at a time), in both legs, both arms down into pinky and ring fingers (weakness noticed when typing and writing). Both ears still with fullness feeling (only one side at a time). I can still walk/run, these symptoms are still present as of today 1/3/21.
35 2021-01-02 pain Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved... Read more
Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved my eyes from right to left. Also had a generalized headache and body aches. On Saturday, 1/02, did have a fever of 100.2 but this has resolved. This morning, 1/03, the sinus pain has improved, still a slight headache and now major conplaint is lower back pain. Also have general malaise. No fever today either.
35 2021-01-03 feeling hot ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th... Read more
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to EOHD since we were so busy. ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER. She was recovering and doing fine. Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.
35 2021-01-03 dizziness I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facili... Read more
I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facility and then left. Sat in my car working for about 8-10 minutes when a sudden rush of heat ran through my body. I felt lightheaded, my tongue was prickly, and I felt like I was going to pass out. I was able to get back into the facility to let them know of the sudden symptoms. At that time I felt like my heart was racing and was diaphoretic. They continued to watch me for another 15-20 minutes, they did have an epi pen but it was not given. I was feeling slightly better and then left again. I waited in my car approximately 20 minutes before deciding it would be safe to drive away. After driving for about 10 minutes I had another rush of heat, lightheadedness, and then I started having shortness of breath. At this time it would have been about 1 hour, maybe longer, since receiving the vaccine. I was not close to an emergency medical facility at that time, and did not feel like my throat was swelling so thought it would be best to try to drive to the nearest ER. I knew I had an epi pen from my work that I could use if needed. I contacted another nurse practitioner who I work with who stayed on the phone with me until I was able to get to a safe place. At that time the symptoms had improved, not resolved. It had been able 20 minutes during this episode. In all, I continued to feel jittery for about 3-4 more hours. Since my symptoms did improve I did not go to the ER. I contacted my health department, Louisville health dept, the following day and reported symptoms to the medical director.
35 2021-01-03 pain in extremity Left arm soreness, Headache 30 mins after, Fever 100.9 T 5am and 9am, monitoring until now
35 2021-01-03 facial paralysis, numbness, tingling Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed ... Read more
Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed with Bells Palsy on 01/04/2021
35 2021-01-03 dizziness Lightheadedness and heart palpatations
35 2021-01-03 pain Moderate local reaction. Swelling, redness, pain, hot to touch, itchy for 5+ days.
35 2021-01-04 feeling hot, weakness, numbness, dizziness, tingling 10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, ... Read more
10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, and palpitations. Patient reported tachycardia with heart rate 160-170's. Transient numbness to hands and perioral region. Presented to ED, was monitored with resolution of symptoms. On 1/4/21 patient presented to ED with tachycardia with HR up to 160s, Episode was severe, causing lightheadedness, "throat squeezing", with bilat UE paresthesias. Episode lasted 20 minutes. Patient evaluated in ED and discharged with outpatient follow up with cardiology and endocrinologist.
35 2021-01-04 pain in extremity Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind o... Read more
Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind of pooling of blood in bottom of mouth; went through several tissues; Mild arm pain; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the left deltoid on 24Dec2020 at a single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medication included sertraline for anxiety. The patient received the first dose of the COVID-19 vaccination at the time of report and wanted to report of a probable side effect that she had about an hour and a half after she got the vaccination. About an hour and a half after she received the vaccination, she started to experience bleeding from gum both sides, bilaterally of both sides of lower gums between cheeks and then also from the inside part of lower lip that lasted for about 3 to 4 minutes. It wasn't necessarily profuse bleeding but it was significant enough to cause pooling, kind of pooling of blood in the bottom of my mouth. And she went through several tissues and then it just spontaneously resolved on its own and haven't had any bleeding since. The patient had them 24 hours but didn't have any further bleeding episodes from anywhere. Since that time, the patient haven't noticed any other symptoms other than some mild arm pain. The bleeding has stopped, it stopped after about 3 to 4 minutes and arm pain kind of persisted but not worsened, not terribly bothersome. No treatment was given for the events. The patient wanted to understand if this is a side effect that's being reported by anybody and also whether a recommendation if she should still get this. Outcome of the event gum bleeding was recovered in Dec2020; event mild arm pain was not recovered. The reporter assessed the events as related to COVID-19 vaccination.
35 2021-01-04 dizziness, pain in extremity Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spont... Read more
Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included hypertension (List of any other medications the patient received within 2 weeks of vaccination: Hypertension medication). On 30Dec2020 14:00, the patient experienced dizziness, metallic taste upon injection, sore arm, headache, muscle aches and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
35 2021-01-04 feeling hot Feeling of warmth, flushing, pruritic, eyelid swelling
35 2021-01-04 pain Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; B... Read more
Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; Body aches; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received first dose (BNT162B2, Lot number Eh9899), via an unspecified route of administration on 28Dec2020 17:30 at 35 years old at Arm Left at single dose for COVID-19 immunization. The medical history included Allergies to Penicillin. The concomitant medications were none. On 28Dec2020 21:30 the patient experienced Severe arm pain, decreased mobility, Headache, Fatigue, Sore throat, Body aches, Feverish. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The information on the batch number has been requested.
35 2021-01-04 pain, feeling hot Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting ... Read more
Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting to eat; Sore; Heart bothered me a little today; This is a spontaneous report from a contactable other Health Professional (Other HCP) (patient). A 35-year-old female Patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek9231) on 29Dec2020 10:30 AM, Intramuscularly, (vaccine location: Left arm) at single dose (first dose) for COVID-19 immunization. Medical history included Mitral valve prolapse (Mvp) and covid (patient had covid prior vaccination). Concomitant medication included naproxen a week before. Patient was allergic to Azithromycin. Patient received no other vaccine in four weeks. Patient experienced Headache, Fatigue, Muscle and joint pain, Chills and heat surges, Sore throat, Not wanting to eat, Sore, Heart bothered me a little today (29Dec2020 11:15). Patient did not receive any treatment. Patient did not have had covid tested post vaccination. The outcome of the events was unknown. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
35 2021-01-04 pain, tenderness I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermato... Read more
I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; feeling like prodromal shingles pain though she never personally had shingles; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 35-year-old female patient received first dose of BNT162B2, intramuscular (right arm), on 18Dec2020 at 11:00, at a single dose, for COVID-19 vaccination. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. On 20Dec2020, the patient had mild tenderness and would describe as a burning sensation around the T1-T3 dermatome area, on the same side of her injection, beginning approximately 1-2 days post vaccination. She was feeling like prodromal shingles pain though she never had shingles. Patient is currently on 10th day post vaccination and continues to have this sensation and mild tenderness but have yet to develop any shingles rash. The patient did not receive treatment for events "I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination." Outcome of the event pain was unknown, while for the remaining events was recovering. Information about lot/batch number has been requested.
35 2021-01-04 tingling Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the followin... Read more
Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the following morning, within 72 hours severe abdominal pain, nausea, vomiting, and diarrhea that lasted 5 days, fatigue, and low grade fever (no higher than 100.8)
35 2021-01-04 pain Nausea; body aches; headache; unable to sleep; This is a spontaneous report from a non-contactable n... Read more
Nausea; body aches; headache; unable to sleep; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Eh9899) solution for injection in the left arm on 29Dec2020 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included asthma, pituitary adenoma, IBS (irritable bowel syndrome) and COVID (prior to vaccination). Concomitant medications were unknown. Past drug history included known allergies: ciprofloxacin hydrochloride (CIPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. In Dec2020, the patient experienced nausea, body aches, headache and unable to sleep. No treatment was provided for the events nausea, body aches, headache and unable to sleep. The outcome of the events nausea, body aches, headache and unable to sleep was recovering. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on 30Dec2020 and result was pending. No follow-up attempts are possible. No further information is expected.
35 2021-01-05 pain AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning... Read more
AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
35 2021-01-05 swollen extremities, pain DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches,... Read more
DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
35 2021-01-05 pain Headache noted the night of vaccine and continues to present time. General fatigue noted 1/5/21 with... Read more
Headache noted the night of vaccine and continues to present time. General fatigue noted 1/5/21 with some body aches. Around 4:30pm on 1/5/21 took 1g acetaminophen for headache. At 5pm 1/5/21 temperature of 99.4 noted. By 6pm 1/5/21 temperature was 99.9 (despite acetaminophen in system). Difficulty sleeping 1/5/21 and awoke with intense chills followed a couple hours later with sweats and temp 100.3. Increased sinus congestion also noted, unrelieved by Sudafed.
35 2021-01-05 vertigo I woke up with significant vertigo and nausea. The vertigo subsided after about 30 minutes. The naus... Read more
I woke up with significant vertigo and nausea. The vertigo subsided after about 30 minutes. The nausea continued throughout the day. Increased nausea with looking down or quick movements throughout the day. Headache that day as well. Intermittent mild nausea the following day. No other sick contacts.
35 2021-01-05 feeling hot, tingling, pain in extremity Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later note... Read more
Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later noted headache. BP 150/70; p 86. Then neck pain, bilateral leg soreness, and hip pain; R foot tingling, felt warm, itching, no rash noted. Treated with 25mg benadryl at 0624 pm; BP 130/82. And went to ED for evaluation via wheelchair/personnel.
35 2021-01-05 dizziness Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed Expand All Collapse ... Read more
Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed Expand All Collapse COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021   Subjective Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting.         ALLERGY REVIEW OF SYSTEMS: All other systems negative Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1216 01/06/21 1229 BP: 124/81 117/81 Pulse: 76 69 SpO2: 99% 100% BS not done; no diabetes or history of hypoglycemia. NO allergies.   Physical Exam Vitals signs reviewed. Constitutional: Appearance: Normal appearance. She is normal weight. HENT: Head: Normocephalic. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Palpations: Abdomen is soft. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert.     Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Patient rested on gurney with head elevated for approximately 15 minutes with symptoms resolving without intervention other than water.       PA-C Electronically Signed 1/6/2021 12:29 PM
35 2021-01-05 tingling Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), art... Read more
Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; This is a spontaneous report from a Non-contactable Physician (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 23Dec2020 at first single dose at arm left for covid-19 immunisation. The patient received the vaccine at hospital. Medical history included migraine, dermatitis atopic. The patient's concomitant medications were not reported. The patient experienced Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache on 24Dec2020. No treatment for events. The outcome of events was recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
35 2021-01-05 pain in extremity arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a no... Read more
arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a non-contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 23Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Covid-19 diagnosed prior to vaccination. Concomitant medications included "OCP" (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Dec2020, the patient experienced arm pain, shooting up to neck. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events arm pain, shooting up to neck was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about batch number cannot be obtained.
35 2021-01-05 feeling hot, dizziness within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, a... Read more
within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, and felt faint
35 2021-01-06 pain in extremity, pain, nerve pain 1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lo... Read more
1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lobe region on the right side of my head every now and then. It has happened about 8 times since vaccine administration. The first time being about 25-30 minutes after vaccination. 2. I have also noticed a sharp pain in the back of my right thigh/upper buttock region that feels either like a nerve or muscle pain. It usually is most noticeable when I first stand up from a sitting position or laying position. If I don't put as much pressure on the heel of my right foot, it isn't as bad and ibuprofen has helped the pain subside, but it has been constant. This was first noticed about 4-5 hours after vaccination received.
35 2021-01-06 pain 12 hours post vaccination woke up and barely could lift right arm, chills, body aches, headache, fev... Read more
12 hours post vaccination woke up and barely could lift right arm, chills, body aches, headache, fever 99.8, extreme fatigue for about 18 hours. Took 650 mg with 800 mg Motrin twice. Symptoms resolved after 18 hours. Fatigue lasted for over 24 hours.
35 2021-01-06 dizziness 35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially e... Read more
35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially experiencing a metallic taste in her mouth, palpitations, and nausea. She felt lightheaded but did not lose consciousness. Her symptoms rapidly improved. Her vital signs remained normal.
35 2021-01-06 dizziness Dizziness, Headache & NauseaVomiting
35 2021-01-06 pain Fever 102.4, severe fatigue, chills, aches, HA; Tylenol with reduced fever. Fever for 24 hours, sym... Read more
Fever 102.4, severe fatigue, chills, aches, HA; Tylenol with reduced fever. Fever for 24 hours, symptoms gradually resolved in 3 days from initiation.
35 2021-01-06 pain HEADACHE, EXTREME FATIGUE ON WEDNESDAY AND BOTH WORSED THEN DEVELOPED ON SUNDAY MUSCLE ACHES, DIARR... Read more
HEADACHE, EXTREME FATIGUE ON WEDNESDAY AND BOTH WORSED THEN DEVELOPED ON SUNDAY MUSCLE ACHES, DIARRHEA, SORE THROAT WENT TO URGENT CARE ON 12/29/2020 (TUESDAY) TESTED FOR STREP AND COVID
35 2021-01-06 lethargy, pain, pain in extremity Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tigh... Read more
Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tightness, shortness of breath, tingling in her throat, heart racing. She stayed and was monitored for an hour. When she got home she took Benadryl which helped her sleep. She continues to have mild shortness-of-breath today. Her left arm is sore and she has body aches. Her temp is 100.6 today. 12/30 1712: While speaking on the phone with her she is speaking in full sentences without apparent dyspnea. 12/31 had bad night - high fever 101.5 at 0100 overnight last night. This morning feels tired, lethargic, and no appetite. She still has body aches. No fever this morning. 1/4 - employee reports she is doing much better today. She says she had a rough weekend but is much better today. She able to get back to her running usually runs 25 miles/week.
35 2021-01-06 numbness Numbness in right arm. Loss of feeling in fingers x 3 days. Following up with PCP.
35 2021-01-06 pain in extremity, dizziness, weakness Woke up with chills, headache, weak, felt like fainting, arm pain. Called off work. Fever of 100.4.
35 2021-01-06 facial paralysis, numbness had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbne... Read more
had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. "facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020. Patient was treated with 60mg of Prednisone for 5 days which was started today." Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-06 facial paralysis, pain it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small ar... Read more
it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small area of her tongue; right eye was irritated a little dry; right eye was irritated a little dry; right sided ear pain; fluid in the ear but no infection; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 35-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on the right side on 21Dec2020 for Covid-19 immunization. Medical history included intermittent hives. Concomitant drug included ongoing cetirizine hydrochloride (ZYRTEC) 5 mg for intermittent hives. The reporting nurse practitioner saw a patient on 31Dec2020 who was vaccinated on 21Dec2020 and had a Bell's Palsy reaction (reported as not serious). She did some research and saw no more incidents in the general population but she wanted to report this. She also wanted to get more information on if the patient should proceed with dose number 2 of the vaccine. The patient developed the Bell's Palsy within 5 minutes after getting the vaccine. She thought it was because she was anxious to get the vaccine, so she brushed it off. The Bell's Palsy was still occurring but per the patient it had improved. On exam she did not have any weakness, facial droop or dumbness with sharp or dull testing. The patient perceived it along the face still and the arm. The reporting nurse practitioner said that the arm was probably not Bell's Palsy, but more related to getting the vaccine in the arm and it hits a nerve. Patient stated that her smile was also unequal and it was difficult for her to close her right eye, although now (as of 31Dec2020) she can. Her right eye was irritated a little dry. Regarding treatment, the patient was started on steroids on 31Dec2020. She did not start her on an anti-viral as she did not want it to impact her immunity to the vaccine. The patient also complained of right sided ear pain. She was unsure if that was related to the Bell's Palsy, but it was also on the right side. There was fluid in the ear but no infection. The pain was still ongoing. The patient also mentioned numbness in a small area of her tongue when she first got the vaccine. This was still ongoing. Outcome of Bell's Palsy was resolving. Outcome of the event numbness in a small area of her tongue, right sided ear pain was not resolved. Outcome of the other events was unknown. The reporting nurse practitioner stated that this was not serious as this was a mild case and was thankfully resolving. The reporting nurse practitioner comment that nothing of history was relevant besides for the last several months (as of 31Dec2020) the patient had been taking 5mg of cetirizine hydrochloride for intermittent hives. She wondered if she had not been taking it how she would have reacted or if the reaction would have been more severe. Information on the lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's Palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-06 feeling cold severe back pain, headache, injection site reaction, fatigue, chills
35 2021-01-06 dizziness tachycardia, sweating, dizziness and nausea.
35 2021-01-07 numbness, pain in extremity, tingling ABOUT 1 HOUR AFTER THE INJECTION WAS GIVEN I BEGAN TO EXPERIENCE NUMBNESS AND TINGLING ON THE 3RD FI... Read more
ABOUT 1 HOUR AFTER THE INJECTION WAS GIVEN I BEGAN TO EXPERIENCE NUMBNESS AND TINGLING ON THE 3RD FINGER OF MY RIGHT ARM, THE ARM THE INJECTION WAS GIVEN IN. LATER THAT AFTERNOON IT HAD SPREAD TO MY RIGHT WRIST AND BY THE TIME I WOKE UP THE NEXT DAY, MY WHOLE ARM WAS NUMB/TINGLY/PAINFUL AND THERE WAS A SWOLLEN LYMPH NODE IN MY UNDERARM ON THE ARM THE VACCINE WAS GIVEN IN. THE NUMBNESS/TINGLING/PAIN FINALLY WENT AWAY 2-3 DAYS LATER.
35 2021-01-07 pain, pain in extremity BODY ACHE (LEFT UPPER ARM) POST COVID VAC. SHOT
35 2021-01-07 pain Body aches, fatigue, headache
35 2021-01-07 pain in extremity COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am... Read more
COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am and complained that the injection was delivered too high and she was experiencing pain at the site. Vaccine placed high on L shoulder, just below acromion process, at or above humeral head. Seemingly placed between acromion process and humeral head, near or in soft tissue/bursa. Site pain is inflammatory in nature and does not seem to affect muscles, but instead is contained within joint itself.
35 2021-01-07 dizziness Dizziness Narrative: employee felt light headed after vaccine, no interventions, passed quickly fel... Read more
Dizziness Narrative: employee felt light headed after vaccine, no interventions, passed quickly felt better after 20min wait time
35 2021-01-07 balance disorder, tingling, dizziness Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holdi... Read more
Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holding onto wall/divider, "felt like might fall down" "tingling in left arm and leg", sweating. BP 100/80 PR 80, 115/87 PR 77, reports has drank 30-40 oz of water in the morning prior Narrative: Rapid Response called
35 2021-01-07 pain in extremity, numbness Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, st... Read more
Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; This is a spontaneous report from a non-contactable other healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced headache, right hand numbing and tingling, and stiff neck. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient underwent post vaccination nasal swab with an unknown result. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
35 2021-01-07 difficulty speaking Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly... Read more
Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
35 2021-01-07 dizziness, pain in extremity I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm w... Read more
I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm was soar and swollen. I didn't take anything, a little difficult to sleep. The next day it started wearing off, I did ice the area.
35 2021-01-07 pain in extremity Injection site soreness, fever 101F, chills/rigors, severe nausea
35 2021-01-07 numbness Intermittent numbness in hands
35 2021-01-07 tingling, weakness, dizziness Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fl... Read more
Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fluids, food Sxs largely resolved after 30 mins of close monitoring, returned to shift feeling a little lightheaded NKA
35 2021-01-07 tingling, numbness Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness... Read more
Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness at the injection site and hives on the left arm where injection was given. Patient went to ER on 01/01/2021 due to numbness and tingling. Received Benadryl at the ER.
35 2021-01-07 dizziness Severe Light headedness and dizziness lasted for about 4 days Headache , Muscle ache , Chills
35 2021-01-07 tingling, numbness Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tin... Read more
Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; This is a spontaneous report from a contactable Other Health Professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 02:30 at single dose for COVID-19 immunization. The patient had no relevant medical history and concurrent conditions. Known allergies: No (Allergies to medications, food, or other products: No). Other medical history: None. Concomitant medication received within 2 weeks of vaccination included biotin, meclizine (MECLOZINE), multivitamin. The patient experienced tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows on 05Jan2021 12:30 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included COVID test post vaccination: Nasal Swab (Prc) on 27Dec2020 with result negative. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Ibuprofen received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about Lot/Batch has been requested.
35 2021-01-07 tenderness acute mild edema to affected forearm with light bruising of unknown origin without known injury; acu... Read more
acute mild edema to affected forearm with light bruising of unknown origin without known injury; acute mild edema to affected forearm with light bruising of unknown origin without known injury; unknown origin without known injury, tenderness to touch; Tennis elbow of opposite vaccine extremity around same time as vaccine, just after; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 10Dec2020 in a hospital at a single dose for COVID vaccination. Medical history included anxiety and chronic migraines with aura. The patient has no known allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccine in four weeks, was not diagnosed with COVID prior to the vaccination, and was not tested for COVID post-vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), bupropion hydrochloride (WELLBUTRIN), and cyclobenzaprine. In Dec2020, the patient had tennis elbow of opposite vaccine extremity around the same time as the vaccine, just after. On 01Jan2021 at 04:00 AM, the patient experienced acute mild edema to affected forearm with light bruising of unknown origin without known injury, tenderness to touch. The patient did not receive any treatment for the events. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect). Information on the lot/batch number has been requested.
35 2021-01-07 pain body aches hours after vaccine, rest, encouraged if needed to f/u with provider as needed
35 2021-01-07 dizziness severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes,... Read more
severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day
35 2021-01-07 pain test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, ... Read more
test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, chills, body aches, joint pain; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5703), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for covid-19 immunization. Administration was done in the hospital. Medical history included seronegative rheumatoid arthritis and allergies to latex and actemra. Concomitant medication included tofacitinib citrate (XELJANZ), and ibuprofen. Eight days after vaccination, on 23Dec2020 at 13:30, the patient came down with fever, chills, body aches, joint pain. The patient was initially tested negative for COVID (nasal swab) and influenza on 27Dec2020 but did test positive for COVID-19 on 29Dec2020 (nasal swab). The patient stated that she knew that the vaccine did not cause COVID however as she was on immunosuppressants (Xeljanz), she wanted to record this information. There was no treatment included for the events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
35 2021-01-08 feeling hot ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th... Read more
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to HD since we were so busy. ? Around 4pm in the afternoon after we closed HD, I went back to the ER. She was recovering and doing fine. Her ER nurse and patient did have a question about receiving the 2nd dose, and I provided the same answer that Dr provided to Dr about taking an Allegra 30 minutes before the second dose. ED Note: Patient presents with symptoms concerning for angioedema or anaphylaxis after immunization with Covid vaccine. Patient described a sensation of warmth and also later tingling in her throat which was treated aggressively with medication for this problem so as to prevent airway closure or further worsening symptoms. Patient was treated with IV fluid hydration along with H1 and H2 blockers, IV steroids and also subcutaneous epinephrine. On my reevaluation, her symptoms completely resolved with treatment. She was without other concerning findings on examination or by history and was without further angioedema or anaphylaxis after period of observation. She was discharged with prescription medication in good condition and asked to return should she have any further problems. Immpression: Angioedema, allergic reaction to vaccine, throat tingling, throat warmth MEDS in ED: Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses diphenhydrAMINE (Benadryl) 25 mg = 0.5 mL once IV push methylPREDNISolone (SOLUMedrol) 125 mg = 2 mL once IV push famotidine (Pepcid) 20 mg = 2 mL once IV push EPINEPHrine 0.3 mg = 0.3 mL once intraMUSCULAR
35 2021-01-08 dizziness Dizziness, headache, feeling faint, nausea, vomiting
35 2021-01-08 dizziness, feeling hot Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body ex... Read more
Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body experience". Increased heart rate (134/m). A&O x 3. Warm, dry. Adult Emergency called and team responded within 2 mins. Pt states symptoms improving rapidly. Transported to ED w/o delay.
35 2021-01-08 pain On 1.8.21, woke up with a temp of 101.8 oral, chills, body aches, terrible headache
35 2021-01-08 feeling hot Severe rash around neck area. Warmth in the area of the rash
35 2021-01-09 feeling cold, dizziness 25min after injection while driving home, I got a cold sensation in the back of my head, trouble bre... Read more
25min after injection while driving home, I got a cold sensation in the back of my head, trouble breathing, racing heart, and lightheadedness. pulled over, paramedics called. no treatment, symptoms passed after 30min. (cold sensations, racing heart, and trouble breathing brief, lightheadedness ~30min)
35 2021-01-09 pain After the second dose I had headache and body aches. More concerning was a build up of fluid around ... Read more
After the second dose I had headache and body aches. More concerning was a build up of fluid around my left armpit and left chest.
35 2021-01-09 pain Entire body achy at midnight. Took total of 2 grams Tylenol, HA and tired x24 hrs
35 2021-01-09 migraine Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of brea... Read more
Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of breath.
35 2021-01-09 swollen extremities Moderate axillary swelling and tenderness, same side as injection. Onset 1/9/21, no treatment sought... Read more
Moderate axillary swelling and tenderness, same side as injection. Onset 1/9/21, no treatment sought as of now.
35 2021-01-09 pain in extremity, dizziness Nauseous, dizzy, sore arm, runny nose for an hour.
35 2021-01-09 pain in extremity, pain On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache,... Read more
On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache, body aches, and nausea also. This was approx 16 hours post dose. I took 600mg of ibuprofen and felt more able to do normal home activities but still tired with a sore arm. 4.5 hours post ibuprofen dose I again had muscle aches, headache, fatigue, and nausea. I also had chills and joint pain. I napped for an hour, took another 600mg ibuprofen, and then napped for another 2.5 hours. After that I felt better at 27 hours post dose but still achy and fatigued. These symptoms had mostly resolved by 31 hours post dose.
35 2021-01-09 pain Severe body aches, joint pain, chills, fever Mild nausea vomiting and abdominal pain
35 2021-01-09 feeling hot Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, ... Read more
Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, feeling hot, fever onset at 0200 1/10/2021 (100.8-100.9), I have taken Tylenol 650mg q 6 hrs. Ibuprofen 800mg once 1/9/21 at 2200.
35 2021-01-09 pain Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild ... Read more
Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks, Red rash under left arm pit, temp of 100.4. Body aches.
35 2021-01-10 pain About 10 hours after vaccine, patient developed nausea, vomiting, diarrhea, and abdominal pain. She ... Read more
About 10 hours after vaccine, patient developed nausea, vomiting, diarrhea, and abdominal pain. She describes these symptoms as severe with multiple, powerful episodes and similar to her Celiac disease when she flares from high gluten meal. She also had low back pain and body aches. The following day symptoms continued. Improved overnight into Jan 10, then worsened after waking up. On Jan 11, no further n/v/d but not feeling back to baseline yet.
35 2021-01-10 pain, weakness Feeling of fatigue, full body muscle ache, low energy
35 2021-01-10 pain I got the shot around 11am on Friday, and felt fine when I went to bed. I woke up around 3am Saturda... Read more
I got the shot around 11am on Friday, and felt fine when I went to bed. I woke up around 3am Saturday morning with a fever, chills, severe body aches and a headache. The fever went down around 6am, and I took Advil and Tylenol to help get it the rest of the way down and help with the body aches and headache. My symptoms started to resolve around noon, and I was just left feeling severely fatigued.
35 2021-01-10 pain I had low grade fever, chills, body aches and joint pains which cause me to barely stand up. These s... Read more
I had low grade fever, chills, body aches and joint pains which cause me to barely stand up. These symptoms lasted for about 24 hours. Since I'm pregnant I couldn't take any Ibuprofen being pregnant(estimated date of delivery) 3/16/2021.
35 2021-01-10 pain I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the ... Read more
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache, All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM. Axillary lymph node is larger than a marble currently. Also at times if I change positions I have a very brief moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me. Neck is the biggest complaint as of now. I called my PCP with the above complaints who referred me to employee health.
35 2021-01-10 pain I received the shot around 11am, and around 3am I woke up with a fever, sweating and chills. I was a... Read more
I received the shot around 11am, and around 3am I woke up with a fever, sweating and chills. I was also experiencing a headache and body aches. My fever went down around 6am, but I was still experiencing severe body aches. The overall affect was similar to the flu. I took some over the counter medications to treat the fever and body aches (Advil and Tylenol) and began feeling better around noon.
35 2021-01-10 dizziness, pain Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficult... Read more
Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficulty focusing on tasks, and light-headedness began around 9:00AM on 1/8/2021, and progressively worsened throughout course of day. Severe body aches and joint pain (entire body) with severe malaise and fatigue began later that evening about 8:00PM on 1/8/2021 until about 12:00PM on 1/9/2021. Took Tylenol 500mg as indicated for 24 hours. Symptoms resolved by mid-afternoon 1/9/2021.
35 2021-01-10 pain Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; H... Read more
Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis. Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported. The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened. She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit. Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt. She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate. The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of "injection site itched a little bit" was unknown. The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-10 pain fever, body aches, chills, headache. called in sick to work.
35 2021-01-11 pain 1/9/21 no pain and no red mark 1/10/21 ? perfect red circle where vaccine was given with pain, hot ?... Read more
1/9/21 no pain and no red mark 1/10/21 ? perfect red circle where vaccine was given with pain, hot ? unable to wear sleeve over spot, difficult to sleep, and could feel it even when breathing 1/11/21 ? marked vaccine area with pen line ? see picture below. Shoulder tender with movement above 90degrees 1/12/21 ? redness is spreading outside of pen more medially, slightly laterally ? shoulder tenderness is still the same level
35 2021-01-11 dizziness, pain 12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever. Vaccine given ... Read more
12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever. Vaccine given 12/18. She was tested for covid 19 on 12/28 and was positive.
35 2021-01-11 dizziness, weakness After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes ... Read more
After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes I drank some water and felt like my bilateral upper thighs were difficult to lift when I tried to walk to my car. I went home and was tachycardic 120-130bpm that continued throughout the night to the point I couldn't sleep my heart was pounding so hard and fast. I was extremely thirsty and dehydrated all night. I continued to have tachycardia for several days despite hydrating. My thighs also continued to feel week for several weeks. I developed a 100.7 F temperature and had flu like symptoms the following days.
35 2021-01-11 vertigo Approximately 12 hours after vaccine present with vertigo, that lasts for approximately 24-28 hrs. 5... Read more
Approximately 12 hours after vaccine present with vertigo, that lasts for approximately 24-28 hrs. 5 days after vaccine started presenting with hives, self resolving, migratory. Some other common side effects already known were also present like chills, sore throat, headache, nauseas, tiredness, pain and induration at injection site.
35 2021-01-11 pain Extreme chills, body aches, nausea, headache, fatigue. Symptoms lasted 24-48hrs after 1st dose, sym... Read more
Extreme chills, body aches, nausea, headache, fatigue. Symptoms lasted 24-48hrs after 1st dose, symptoms persisting past 4 days on 2nd dose. 2 weeks after 1st dose positive ANA titer was found after an episode of Raynoud?s that had never been experienced previously.
35 2021-01-11 dizziness Feeling dizzy; head hurt; fatigued; This is a spontaneous report from a contactable other health car... Read more
Feeling dizzy; head hurt; fatigued; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old non-pregnant female patient received bnt162b2 (BNT162B2, lot no. and expiry date was unknown), via an unspecified route of administration in left arm on 03Jan2021 14:00 at single dose for Covid-19 immunization. The patient medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling dizzy and her head hurt very bad and so fatigued on 05Jan2021. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. Information about Lot/Batch number is requested.
35 2021-01-11 tingling Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but d... Read more
Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but doesn?t appear to be
35 2021-01-11 numbness I started noticing swelling and altered sensation in my right lower arm about 10 minutes after injec... Read more
I started noticing swelling and altered sensation in my right lower arm about 10 minutes after injection. The swelling subsided but numbness lingered. Then around 10am I started feeling numbness in my right neck, jaw and ear. Numbness improved after taking half tab of benadryl.
35 2021-01-11 numbness, facial paralysis, tingling Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of to... Read more
Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure. The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship. However, the Bell's palsy may possibly represent a concurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-11 pain, migraine Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/b... Read more
Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/blistering day 2after vaccine Severe body aches and cramps day 2 after vaccine
35 2021-01-11 migraine On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccinatio... Read more
On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccination, fever 102, headache, and joint pain. Chills. Migratory migraine. Second vaccine Jan 8th.
35 2021-01-11 pain in extremity Severe sore arm for 2 days after vaccine. Rash/hives for 3 days after vaccine
35 2021-01-11 pain, weakness Weakness, chills, nausea and excruciating stubbing pain in L shoulder with even minor movement
35 2021-01-11 dizziness aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot fl... Read more
aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot flashes,and a numb lip, cold and shivering. they started o2 at 4liters via nasal canula and gave her 2 Benadryl 25mg oral tabs. At 10:40 she said she felt better, not dizzy, lip not numb, and wasn't feeling cold. She said she would contact her pcp and let him know. She felt good enough to drive off.
35 2021-01-11 dizziness broke out in hives, sweaty, pale, complained of dizziness and nausea
35 2021-01-11 dizziness collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distr... Read more
collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distress with stridor; respiratory distress with stridor; dizziness/rapid progression of symptoms; not limited to abdominal pain/rapid progression of symptoms; blood pressure abnormality/rapid progression of symptoms; chest pain/rapid progression of symptoms; drooling/rapid progression of symptoms; increased swelling/rapid progression of symptoms; wheezing; dyspnea and increased work of breathing; skin changes; tongue swelling and vomiting; tongue swelling and vomiting; This is a spontaneous report from a non-contactable other health professional. A 35-year-old female patient (Age at vaccination: 35) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience dizziness. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality, chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. Treatment included: no therapy. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the collapse, hypotension, respiratory distress and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including BP measurements, chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-11 dizziness, tingling, migraine nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itchi... Read more
nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itching. migraine. nausea, dizziness. positive D Dimer. Shortness of breath Treatment: IV fluids, Reglan. IV Tylenol. Covid test- negative. Na 121.
35 2021-01-12 pain 12 hours after 2nd dose I ran a fever consistently for about 24 hours, had a headache body aches chi... Read more
12 hours after 2nd dose I ran a fever consistently for about 24 hours, had a headache body aches chills and congestion. After 24 hours of the fever I feel completely normal.
35 2021-01-12 pain 16 hours post vaccine #2 had fever of 102, headache, fatigue, body aches and chills. Ibuprofen 600 m... Read more
16 hours post vaccine #2 had fever of 102, headache, fatigue, body aches and chills. Ibuprofen 600 mg taken at 20 hours post vaccine. Improvement notified and fever decreased. At 26 hours post vaccine headache notified and fever of 99.6. Tylenol 500 mg taken. Today (1/13) 2 days past vaccine heart rate has been in 100s -110s all day. Headache notified. At 48 hours post vaccine fever developed of 100.5, aches, headache. Tylenol 650mg taken
35 2021-01-12 dizziness About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty brea... Read more
About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty breathing. VS stable. A rapid response was called but patient monitored. Dizziness resolved.
35 2021-01-12 pain Body aches, fatigue, headache, sore throat, very sensitive skin-felt like a sunburn All but fatigue... Read more
Body aches, fatigue, headache, sore throat, very sensitive skin-felt like a sunburn All but fatigue resolved after 22 hours
35 2021-01-12 dizziness Described feeling woozy/queezy slightly dizzy. Denies nausea & SOB. Started aroumd 5 mintes after sh... Read more
Described feeling woozy/queezy slightly dizzy. Denies nausea & SOB. Started aroumd 5 mintes after shot, resolved 10 minutes after vitals stable.
35 2021-01-12 pain Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful,... Read more
Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful, pain and swelling at injection site
35 2021-01-12 feeling hot H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her... Read more
H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her, feels warm, tired, heat surge, loss of appetite, SOB, Had COVID May 2020.
35 2021-01-12 pain I received the 2nd dose of the Pfizer COVID19 on 1/12/21 at approx. 1:30pm. The next day (1/13/21) a... Read more
I received the 2nd dose of the Pfizer COVID19 on 1/12/21 at approx. 1:30pm. The next day (1/13/21) at approximately 05:30am I awoke feeling feverish with chills and aches. I treated this side effect 400mg ibuprofen Q6HPRN twice during the day and had an Epsom salt bath. The next morning, I was fully recovered.
35 2021-01-12 pain Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days. 2 days after ... Read more
Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days. 2 days after the shot, she got hives. She also got bodyaches, which lasted 4 days, headaches, which persistent at day 13, fatigue, which persists at day 13, and head congestion, which persists at day 13. She feels like she had COVID all over again, although she is improving. She is very hesistant to take the second immunization, for fear of what it might do to her. Of note, she had moderately severe COVID starting on July 10, 2020. She was almost hospitalized. She had long hauler's syndrome, and it took her 11 weeks to feel well enough to be able to work full time again.
35 2021-01-12 dizziness Pfizer-BioNTech COVID-19 Vaccine on 1/12/2021, patient experienced extreme fatigue and lightheadedne... Read more
Pfizer-BioNTech COVID-19 Vaccine on 1/12/2021, patient experienced extreme fatigue and lightheadedness after receiving the vaccine. Patient did not go to ED for evaluation.
35 2021-01-12 dizziness RECEIVED 2ND DOSE OF PFIZER COVID VACCINE 1/5/21 1600. DURING 15 MIN OBSERVATION COMPLAINED OF FEEL... Read more
RECEIVED 2ND DOSE OF PFIZER COVID VACCINE 1/5/21 1600. DURING 15 MIN OBSERVATION COMPLAINED OF FEELING DIZZY/LIGHTHEADED. FELT BETTER AFTER EXTENDED OBSERVATION. STATED SHE FLE FINE TO OBSERVER. ON 1/6 WENT TO WORK AND FELT SICK WITH HEADACHE, FATIGUE, FEVER, CHILLS. PATIENT WENT TO ER AND WAS DISCHARGED AFTER 30 MINS
35 2021-01-12 pain She developed fevers to 101 that night, and chills, which lasted 2 days. 2 days after immunization,... Read more
She developed fevers to 101 that night, and chills, which lasted 2 days. 2 days after immunization, she got hives, which resolved. She got body aches, which lasted 4 days, and headaches, fatigue, and head congestion, which are improving, but persist at day 13. Of note, she had COVID on 7/10/2020 and was a long hauler. She was nearly hospitalized. It took her 11 weeks to fully recover.
35 2021-01-12 pain The patient was a lactating mother; The patient was a lactating mother; Fever 102; Malaise; Headache... Read more
The patient was a lactating mother; The patient was a lactating mother; Fever 102; Malaise; Headache; Body aches; left axillary pain swelling - lymphedema; left axillary pain swelling - lymphedema; left axillary pain swelling - lymphedema; 1st dose of BNT162B2 on 18Dec2020 13:15/2nd dose on 05Jan2021 13:45; This is a spontaneous report from a contactable other healthcare professional (patient) reported for both mother and baby. This is the maternal report. A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration in left arm on 05Jan2021 13:45 at single dose for Covid-19 immunisation. Medical history included hx mild ehler's danlos syndrome, sulfa and latex sensitivity. No covid-prior-vaccination. No covid-tested-post-vaccination. The patient's concomitant medications included Prenatal. The patient previously received 1st dose of BNT162B2 (lot# EK5730) in left arm on 18Dec2020 13:15 for Covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 102, malaise, severe headache and body aches, left axillary pain swelling - lymphedema on 06Jan2021 12:15. The patient was a lactating mother. The patient underwent lab tests and procedures which included body temperature: 102 on 06Jan2021. The outcome of events was recovering. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021012166 child case
35 2021-01-12 pain The symptoms was chills, body aches, very tired and no fever.(estimated date of delivery 5/17/2021)
35 2021-01-12 pain Very bad body aches and fatigue that lasted 48 hours
35 2021-01-12 pain in extremity arm sore, sore throat,nasal congestion, chest hurt when taking deep breath,sob ,headache, pulse 100,... Read more
arm sore, sore throat,nasal congestion, chest hurt when taking deep breath,sob ,headache, pulse 100, advised to see PCP
35 2021-01-12 feeling hot h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, ... Read more
h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, warm surges.
35 2021-01-13 pain 12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint... Read more
12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint pain, headache, malaise. First vaccine side effects lasted 1-2 days. Just had second vaccine yesterday, symptoms have not resolved yet
35 2021-01-13 migraine About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to ... Read more
About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to 180/120 and I was sent to the ER (Hospital) for monitoring. After some time it leveled out and I was released home to rest. That night and the next day I had a migrane, felt sluggish and really couldnt do anything. I took tylenol and motrin to help with the pain.
35 2021-01-13 dizziness Approximately 10 minutes after receiving the vaccine the patient became clammy and light headed. VS ... Read more
Approximately 10 minutes after receiving the vaccine the patient became clammy and light headed. VS were stable and patient stayed an extra 30 minutes until she started feeling better. With follow up call, patient stated that she has headache, nausea and fatigue
35 2021-01-13 dizziness Associate reports Fever, headache, and sweating that began on 1/13/21, and fatigue, dizziness, "heav... Read more
Associate reports Fever, headache, and sweating that began on 1/13/21, and fatigue, dizziness, "heavy head", tachycardia, and hypertension starting on 1/14/21. Advised to seek medical treatment.
35 2021-01-13 weakness Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous ... Read more
Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown), intramuscularly, on 05Jan2021 (at the age of 35-years old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included Thalassaemia from an unknown date and COVID-19 on an unknown date. The patient's historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730) on 17Dec2020 (at the age of 35-years-old) at unspecified dose in the left arm for COVID vaccination.The patient has no allergies to medications, food, or other products. The patient was administered the vaccine in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had been diagnosed with COVID-19 on an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccinations. On 05Jan2021 at 23:30 the patient experienced chills, low-grade fever (100.9), muscle aches, weakness and diarrhea. The patient did not receive any treatment for the events. The clinical outcome of the events was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
35 2021-01-13 migraine Fatigued about 8 pm last night Woke up groggy 10 am - migraine started 11 am - shortness of breath... Read more
Fatigued about 8 pm last night Woke up groggy 10 am - migraine started 11 am - shortness of breath and fatigued (out of it really bad) Noon - heaviness in the chest 12:45 (current time) Aches in my shoulders, Migraine in my right temple area, short of breath, chest burning, head feels heavy to my neck. Similar symptoms to when I had Covid in the end of October.
35 2021-01-13 pain Injection site pain, body aches, joint pain, Improving.
35 2021-01-13 dizziness Nausea Vomiting Diarrhea Headache Dizziness (4 days)
35 2021-01-13 pain Numbness, tingling in R arm distal to injection site. Swelling at injection site. Restricted movemen... Read more
Numbness, tingling in R arm distal to injection site. Swelling at injection site. Restricted movement due to pain.
35 2021-01-13 dizziness Previous report filed 12/23. On 12/25 I woke up with rash on face, neck, arms, and chest. Itchy. Too... Read more
Previous report filed 12/23. On 12/25 I woke up with rash on face, neck, arms, and chest. Itchy. Took Benadryl. Went away. On 12/27 I have another bout of palpitations that lasted 30 mins with heart rate at 130s at rest with dizziness and lightheaded ness.
35 2021-01-13 migraine, pain Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Head... Read more
Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Headaches; This is a spontaneous report from a contactable Other Health Professional (patient). A 35 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (lot EK5230) via Intramuscular on 16Dec2020 11:30 in the left arm at single dose, second dose via Intramuscular on 06Jan2021 11:00 in the left arm at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Caller did not experience any side effects after the first dose. After the second dose, caller experienced, fever, chills, body aches, muscle tightness and headache. Today the caller also experienced shortness of breathe and a rapid heart rate. Fever; She said that she noticed her fever at 0130 07Jan2021. He fever started at 100.3 at 0130 and at 0400 it was 100.8. She took it at 1000 and it was 101. She has not taken her temperature since. Chills: She woke her up at 0130 07Jan2021 she said that she sleeps with a electric heated blanket and she woke up cold. Body aches: She noticed that she had the body aches and pain at 0130 07Jan2021. She said that she has not been able to sleep because the pain has been so bad. Muscle tightness: She said that it hurts to stand up and walk. She stated that she had to get a Covid test this morning so she had to move. She noticed the muscle tightness at 0130 07Jan2021 along with the body aches. Headaches: caller said that she noticed her headache around 0130 07Jan2021. She said that it is a dull achy headache. She stated that she get migraines and thought it was because of her fever. Shortness Of Breath: She said that she noticed she was short of breath around 1230 07Jan2021. She stated that it is hard to breath right now and feels like someone is standing on her chest. Rapid heart rate: Her watch at 1230 07Jan2021 said that she had a 116 heart rate and that was at rest. Outcome of event Chills was recovering, while outcome of other events was not recovered.
35 2021-01-13 dizziness Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes afte... Read more
Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after covid vaccine, dizziness, headache, lightheadedness; severe chest tightness and pressure; very hard to breathe in, more than 30 minutes after covid vaccine; Dizziness /lightheadedness; headache; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, asthma, diabetes, sleep apnea, low immune system, post-traumatic stress disorder (PTSD), depression, panic attacks, insomnia, borderline personality disorder, and known allergies to medications, food, or other product (10 total). Concomitant medications included adult tetanus vaccine on 04Jan2021 received at right arm, for immunization (within 4 weeks prior to the COVID vaccine); first dose of botulinum toxin type a (BOTOX) on 06Jan2021 at single (31 shots in 7 muscle groups) for migraines (within 4 weeks prior to the COVID vaccine); and clindamycin antibiotic for infection in finger (took within in two weeks). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. On 09Jan2021 11:00, the patient experienced sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after COVID vaccine, "dizziness/lightheadedness", and headache. The above mentioned events resulted in emergency room/department or urgent care visit, and patient received breathing treatment, oxygen for over an hour for these events. The outcome of the events was unknown. The reporter considered the events as non-serious.
35 2021-01-13 pain The evening I got the shot I felt my muscles starting to ache. The next morning when I woke up I wa... Read more
The evening I got the shot I felt my muscles starting to ache. The next morning when I woke up I was achy, but still went to work. Around 11:00 am on 1/13/21 I started to feel flushed and the chills. Took my temp and it was 100.3 F. I was achy all over and had a headache too.
35 2021-01-13 pain Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would tak... Read more
Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would take the pain away.; Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would take the pain away.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received bnt162b2 (lot:EK9231), via an unspecified route of administration in the left arm on 05Jan2021,16:30 at a single dose for covid-19 immunization. The patient's medical history included depression and migraines and covid-19 all from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included escitalopram (ESCITALOPRAM). On 05Jan2021 at 18:00, the patient experienced very intense headache and general body ache. Patient took acetaminophen and naproxen and nothing would take the pain away. Therapeutic measures were taken as a result of very intense headache and general body ache included acetaminophen and naproxen sodium but nothing would take the pain away. The outcome of the events was recovered on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination.
35 2021-01-13 feeling hot Voiced s/s of itching @ 1232pm. Voices s/s to L side of face. Slight redness noted bilateral cheek... Read more
Voiced s/s of itching @ 1232pm. Voices s/s to L side of face. Slight redness noted bilateral cheeks and L ear. Continued to c/o s/s @ 1238 no relief. Benadryl 25mg given @ 1238. Redness still remains to area, heat also noted to L ear. Remains in observation @ 1238. Remains to have slight redness to areas. Denies any other s/s of distress. Left observation @ 1308. Voices allergies of Peanuts,Tree Nuts, Latex, Melons, and Bananas. Does have chronic illness's of Asthma, and Seasonal Allergies.
35 2021-01-13 pain in extremity, migraine Woke up with a very sore arm. About 10 am Migraine started 11 am Tired "feeling out of it" Noon -... Read more
Woke up with a very sore arm. About 10 am Migraine started 11 am Tired "feeling out of it" Noon - Short of breath Currently 12:30 Muscle soreness in shoulders, migraine worse, heavy chest
35 2021-01-13 pain fever off and on/ temperature was 100.4; Chills; severe body aches; This is a spontaneous report fro... Read more
fever off and on/ temperature was 100.4; Chills; severe body aches; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 16Dec2020 at 0.3 mL, single; then the second dose on the left arm (reported as 'left shoulder') to 05Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included Raynaud's disease probably diagnosed like 7 years ago, but she was not taking anything for it. There were no concomitant medications. The patient reported that she was a dietician. She works in the ICU at the hospital, but was not a healthcare professional. She just got the second dose on Tuesday (05Jan2021), and had severe body aches, fever on and off, and chills with the body aches. Severe body aches started Tuesday evening, but were not really bad, she was just achy, then around midnight on Tuesday, they became severe and she had a fever. They resolved kind of this morning, right now she is a little achy, not like before, where her full body was hurting, it hurt to lay down or do anything, she had to lay in bed for 24 hours. Fever started at midnight, so she guess on 06Jan2020, now she doesn't feel feverish, but she didn't check, she thinks it broke again last night, she was taking Advil. She took acetaminophen (TYLENOL) the first night, at midnight, when she got the fever, she took acetaminophen, and tried to go back to sleep, and woke up at 6AM, with severe body aches still, and her temperature was 100.4 so she took ibuprofen (ADVIL). Acetaminophen for some reason bothers her stomach, so she took ibuprofen. She felt like the acetaminophen didn't do anything. She came to work today. After that, she was taking ibuprofen yesterday through the day. The chills were along with the fever and body aches and are not ongoing right now. She had symptoms after the first round of the Pfizer COVID vaccine too, but they were not as bad. The outcome of the event severe body aches was recovering, of chills was recovered on an unspecified date, and of fever was unknown.
35 2021-01-13 dizziness headaches for rest of day; severe dizziness; chest palpitations; extreme muscle weakness; projectile... Read more
headaches for rest of day; severe dizziness; chest palpitations; extreme muscle weakness; projectile vomiting- all x15 minutes; fever of 101.1; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included anxiety, osteoarthritis from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), paracetamol (TYLENOL), ibuprofen. Patient previously received first dose of bnt162b2 (Batch/lot number: EH9899) intramuscular on 16Dec2020 14:45 at single dose at right arm for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after paracetamol, general fatigue, headaches for rest of day from 07Jan2021 08:30 am with outcome of recovering. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered as non-serious.
35 2021-01-14 pain in extremity 1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; ... Read more
1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on 18Dec2020 (at the age of 35 years old) as a single dose in the right arm via unknown route of administration for COVID-19 immunization at hospital facility. Relevant medical history was unknown. It was unknown if patient has any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after the first dose, the patient experienced mild headache and mild arm soreness. No treatment was received for the events mild headache and mild arm soreness. The outcome of the events mild headache and mild arm soreness was unknown. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
35 2021-01-14 pain Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health pr... Read more
Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 35-year-old female patient (no pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: El1283) via an unspecified route of administration on the left arm on 08Jan2021 02:00 PM at single dose for COVID-19 immunisation. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek5730) via an unspecified route of administration on the left arm on 18Dec2020 03:45 PM at single dose for COVID-19 immunisation. Medical history included known allergy to Bactrum and ciprofloxacin hydrochloride monohydrate (CIPRO). The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lisdexamfetamine mesilate (VYVANSE). No other vaccine in four weeks. On 09Jan2021 at 04:00 AM, patient experienced body aches, fever, chills, headache. Nasal swab covid test post vaccination on 28Dec2020 was negative. No treatment received for the events. The outcome of events was unknown.
35 2021-01-14 feeling cold Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present aft... Read more
Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present after the first dose (12/22) except for diarrhea, a rash developed one week after the first vaccine)
35 2021-01-14 tenderness Complaints of fever, tachycardia after vaccination,myalgias, chest ache, axillary adenopathy and ten... Read more
Complaints of fever, tachycardia after vaccination,myalgias, chest ache, axillary adenopathy and tenderness.
35 2021-01-14 pain FEVER (101.1), RUNNY NOSE, COUGH, ACHY, AND TIRED
35 2021-01-14 weakness, pain in extremity Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Inje... Read more
Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Injection site redness and swelling
35 2021-01-14 pain Initially headache and body aches. Within 24 hours developed chest pain, dyspnea on exertion and sho... Read more
Initially headache and body aches. Within 24 hours developed chest pain, dyspnea on exertion and shortness of breath. Patient still currently hospitalized.
35 2021-01-14 numbness Left sided scalp and facial numbness 5 minutes after vaccine. Left sided arm numbness 10 minutes aft... Read more
Left sided scalp and facial numbness 5 minutes after vaccine. Left sided arm numbness 10 minutes after. Seen in ED at Hospital with normal saline iv, Benadryl iv and solumedrol iv. Head ct completed which was negative. No improvement in symptoms. Discharged home. 1/9 woke up with left sided body numbness. Seen at Hospital MRI brain completed, 1/10 numbness and pain to left side of body. Start medrol dose pack. 1/11 saw PCP. 1/14 MRI brain with iv contrast. 1/15 completed medrol dose pack, continued symptoms
35 2021-01-14 numbness Patient felt numbness on her left cheek and developed hives on her forehead within 4 hours or recei... Read more
Patient felt numbness on her left cheek and developed hives on her forehead within 4 hours or receiving the Pfizer covid-19 vaccine. Resolved within 24 hours without treatment.
35 2021-01-14 dizziness Patient reports that she received her second vaccination for COVID 19 (Pfizer) and was feeling well ... Read more
Patient reports that she received her second vaccination for COVID 19 (Pfizer) and was feeling well initially but after 10-15 minutes stood up and got acutely dizzy. Denies any associated pain, nausea, palpitations, sob. Feels perfectly well at time of my evaluation: all symptoms resolved and patient is requesting to be discharged to go to work.
35 2021-01-14 dizziness, pain Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous re... Read more
Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020). On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
35 2021-01-14 lightheadedness Presyncope.
35 2021-01-14 pain in extremity, pain STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT T... Read more
STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT THE DAY I STARTED TO GET A HEADACHE AND MY ARM WAS STARTING TO HURT ALSO, THE NEXT DAY I WOKE UP WITH MY BODY HURTING AND FEELING SICK TO MY STOMACH. IT TOOK ANOTHER DAY FOR ME TO FEEL BACK TO MYSELF.
35 2021-01-14 pain, pain in extremity Sore arm, body aches, chills, headache. By 48 hours most of the symptoms had faded to very minor. Ex... Read more
Sore arm, body aches, chills, headache. By 48 hours most of the symptoms had faded to very minor. Exhausted within hours of the shot.
35 2021-01-14 lethargy Sore throat; congested; 2nd dose - lethargic for 24 hours.; intense muscle and joint pain for about ... Read more
Sore throat; congested; 2nd dose - lethargic for 24 hours.; intense muscle and joint pain for about 48 hours from proximal kneels to neck (hurt to move, shoulder flexibility pain free range 0-30 degrees, couldn't lay on right arm).; intense muscle and joint pain for about 48 hours from proximal kneels to neck (hurt to move, shoulder flexibility pain free range 0-30 degrees, couldn't lay on right arm).; first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020/ second dose of BNT162B2 on 06Jan2021; first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020/ second dose of BNT162B2 on 06Jan2021; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiration date 30Apr2021), via an unspecified route of administration on right arm at 08:30 AM on 06Jan2021 at single dose for COVID-19 immunization. Medical history included hypothyroid. Concomitant medication included levothyroxine, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at single dose for COVID-19 immunization and experienced minimal pain right deltoid area. For the second dose, the patient experienced lethargic for 24 hours, intense muscle and joint pain for about 48 hours from proximal kneels to neck (hurt to move, shoulder flexibility pain free range 0-30 degrees, couldn't lay on right arm). Took Tylenol to decrease muscle and joint pain, which helped. Day 4 post vaccine on 10Jan2021, slight sore throat, congested, but muscle and joint pain generally resolved. It was only day 4. The outcome of events muscle pain and joint pain was recovered on 10Jan2021, the outcome of reset events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.
35 2021-01-14 dizziness, tingling, pain This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bn... Read more
This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Immediately after receiving the first dose of the vaccine, the patient reported having dizziness and tingling throughout her body, she could not feel her hands, the patient was not anxious. After that, her heart began to pound and it was difficult for her to breathe, after a minute she felt her heartbeat begin to normalize. After 30 minutes she began to normalize, but she went to the emergency room and began to feel nausea, her body hurt and her heart rate was 140 bpm, the episode lasted 30 seconds. The outcome of events was unknown. Information on the Batch/Lot number has been requested.
35 2021-01-14 pain chest tightness red rash around mouth body aches swollen lymph node on right side side of neck
35 2021-01-14 pain red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other heal... Read more
red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on Left arm from 08Jan2021 12:45 to 08Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. On 08Jan2021 at 18:45 (6 hours after receiving vaccine), the patient broke out in red hives, experienced chills, body aches and low fever. The outcome of the events was recovered. No treatment was given for the events. Since the vaccination, the patient has not been tested for COVID-19.
35 2021-01-14 pain vaccinated 01/13/2021, at 0830. Her co-worker called down this afternoon and reported that sometime... Read more
vaccinated 01/13/2021, at 0830. Her co-worker called down this afternoon and reported that sometime between 11:30 am and noon, Patient started having cold sweats, nausea, low grade temp, and body aches. She did vomit once, but had just eaten lunch.
35 2021-01-15 pain, weakness Developed fever Sunday night into Monday along with severe body aches, joints pain and weakness. too... Read more
Developed fever Sunday night into Monday along with severe body aches, joints pain and weakness. took Tylenol 500mg every 6 hours. on Tuesday symptoms continued. Wednesday felt little better with no fever but body ache and joint pain continued. Was out from work for 3 days. Weakness and joint pain is still there (today is Saturday). will continue to monitor
35 2021-01-15 dizziness That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I hav... Read more
That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I have taken amlodipine now I have felt lightheaded and less cognitively sharp than normal basically the entire day. I received the above Pfizer COVID-19 vaccine around 12:45 PM, within about 3-5 minutes of receiving the vaccine and standing in line to check out I suddenly felt I was going to loss consciousness/collapse so started lowering myself to the ground and then became unconscious and fell. Healthcare staff informed me I was unconscious for about 20-30 seconds. I woke up and initially felt confused, but quickly realized what had happened. Then I felt nauseated, had some stomach cramps and thought I was going to have diarrhea. They considered giving me Epi for possible anaphylaxis, but I requested they observe further for any skin reaction/hives, airway symptoms, etc given I was skeptical the syncope may have been fully or partially related to the amlodipine I took that morning. Symptoms slowly improved over 20-30 minutes, but the lightheaded feeling and nauseated lasted hours. No Epipen, medications, or interventions were needed.
35 2021-01-16 vertigo Sudden onset unilateral (left) sensorineural hearing loss and severe vertigo
35 2021-01-17 dizziness Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache ... Read more
Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache and shortness of breath. Required IV fluids, EKG, labs, telehealth visit, cardiology referral and placed on Metoprolol for suspected POTS. Currently still having orthostatic tachycardia 7 days after onset of symptoms and pending cardiology referral.
35 2021-01-17 feeling hot Started feeling hot, redness all over body and itching that lasted 24 hours. Bilateral neck itching... Read more
Started feeling hot, redness all over body and itching that lasted 24 hours. Bilateral neck itching/redness and hives remain. Still occurring 1 week after vaccine. Worse at night.
35 2021-01-19 pain in extremity 1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine... Read more
1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine and require Motrin
35 2021-01-19 pain in extremity, feeling cold, dizziness, pain Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I sta... Read more
Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I started to get a headache and get very tired. Then around 5 I started to feel intense: Headache Chills/cold Dizzy/light headed/almost fell over several times Muscle weakness, could not carry anything or lift Muscles in face felt like they were melting down/stroke sensation Exhaustion Sore/achy everywhere Tender left arm where shot was Could not think/memory was gone/could not put together a sentence Tightness chest/hard to breath Could not keep eyes open Had to lay down and sleep with long pants long sweater, jacket and 3 blankets I woke up the next morning and some of my symptoms were gone except I still felt tired and had some achy ness, pain and left arm hurt and had shooting pain in joints Shooting severe pain in each joint, laster for 3 days, most severe in joints where I received vaccine but also in wrists, shoulder, elbows, hips, knees, ankles At day 5 my left arm is still sore including muscles around injection site
35 2021-01-19 pain, pain in extremity Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue day 3 fatigue day 4 headac... Read more
Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue day 3 fatigue day 4 headache day 5 headache day 6 swollen neck lymph nodes as well as armpits and body aches
35 2021-01-19 tenderness, pain in extremity Deep muscle pain, right arm for over 24 hours, resolved with Aleve 440 mg x 2. Right axillary/breas... Read more
Deep muscle pain, right arm for over 24 hours, resolved with Aleve 440 mg x 2. Right axillary/breast tenderness beginning 36 hours after injection. Mental sluggishness beginning about 12 hours after injection, resolved with sleep.
35 2021-01-19 feeling hot, weakness, pain, tremor Developed fever of 101.3 at it's highest (yesterday evening). Accompanied by sweats (soaked through ... Read more
Developed fever of 101.3 at it's highest (yesterday evening). Accompanied by sweats (soaked through clothes/bed sheets), chills/trembles, fatigue, general aches and weakness, acute soreness at the muscle. Following morning woke up still with 100F temp, last took tylenol at 8am, fever has since remained down/normal (it is now 3pm). Still with some sweats/feeling hot, though temp is staying normal.
35 2021-01-19 pain, weakness Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the show... Read more
Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the shower I became weak, ears started blocking, and started to have tunnel vision. Progressively got worse and was able to sit with head between legs. Took about 1 minute before I didn't feel like I was going to pass out. Shaky and weak after. Pulse 78 and oxygen level ok. Completed virtual visit and no further medical treatment advised unless symptoms got worse, but advised it was likely a vaccine reaction. Shortly after a bad headache and body aches developed (expected side effects).
35 2021-01-19 pain Fever 102.6, chills, body aches, extreme fatigue, headache and nausea. Started 2.5 hrs after vaccina... Read more
Fever 102.6, chills, body aches, extreme fatigue, headache and nausea. Started 2.5 hrs after vaccination and has continued. Following up with PCP for further actions to return to work
35 2021-01-19 pain Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and... Read more
Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and back spasms
35 2021-01-19 numbness, tingling Patient reported within 5 minutes of injection arm was tingling and numb and felt it was beginning t... Read more
Patient reported within 5 minutes of injection arm was tingling and numb and felt it was beginning to swell. Patient was given dose of oral benadryl and monitored for additional 15 minutes. Patient started to complain of stomach pain and heaviness in chest. Was sent to ER where she complained of difficulty swallowing, increased heaviness in chest, and arm tingling. Patient reported ER gave her a dose of a steroid. She was released to pharmacy with prescriptions for EpiPen and steroids.
35 2021-01-19 pain in extremity Sore arm and headache.
35 2021-01-19 pain body aches, chills, temp 101.4, mild SOB, site pain (site hot and swollen)
35 2021-01-19 pain body aches; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for h... Read more
body aches; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 08Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies. Concomitant medications included omeprazole and Multivitamin. The patient historic vaccine included the first dose of BNT162B2 received on 18Dec2020 07:30 AM at Left arm for covid-19 immunization, 1st dose symptoms started about 4hrs after: Nausea, body aches, fatigue, severe headache-all lasting 3-4 days. The patient experienced on and off headaches, body aches, fatigue all starting around 18-20 hours post second injection on 09Jan2021 and lasting less than 48 hours. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
35 2021-01-19 pain nausea; body aches; fatigue; severe headache; This is a spontaneous report from a contactable nurse ... Read more
nausea; body aches; fatigue; severe headache; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 18Dec2020 at 07:30 AM, in left arm, for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. Concomitant medications were not reported. About 4 hours after vaccination, on 18Dec2020 at 11:30 AM, the patient experienced nausea, body aches, fatigue and severe headache, all lasting 3-4 days. The events resolved on an unspecified date in Dec2020 without any treatment. COVID was not tested post vaccination. The second dose of BNT162B2 vaccine dose was given on 08Jan2021 at 14:30.
35 2021-01-21 feeling hot "Feeling hot temp 97.7. 10:53 BP 173/97 HR 139 11:05 BP 134/70 HR 94 - asymptomatic Educated pt to ... Read more
"Feeling hot temp 97.7. 10:53 BP 173/97 HR 139 11:05 BP 134/70 HR 94 - asymptomatic Educated pt to notify manager of any additional symptoms Pt returned at 1108 w/ cc palpitations, hot, shaky and difficulty swallowing. Assessed and sent to ED. BP 159/104. In the ED, symptoms resolved and pt discharged at 13:29. "
35 2021-01-21 bell's palsy Bell's palsy. on prednisone 60 mg daily. improving
35 2021-01-21 feeling hot Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next mo... Read more
Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next morning feeling like hit by a bus with so many muscle aches. Also was warm/hot most of the day. Didn't feel good in general. Headache came and went most of the day. The next morning still felt 'off', but not horrible like the previous day.
35 2021-01-21 numbness, weakness Patient reported all energy and strength was wiped out of her. She slowly regained over a few days.... Read more
Patient reported all energy and strength was wiped out of her. She slowly regained over a few days. She has numbness and loss of sensation in whole left side of body, limp and sluggish. Went to ER 01/18/20 and they thought was overload of immune system. They suggested her to report. Symptoms did not subside until 01/22/21, gradually the feeling came back, with rest. She was off work the last week to rest up.
35 2021-01-21 pain, nerve pain, weakness Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/... Read more
Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/10 muscle pain and partial awareness to time place and location. Fatigue and pain and nauseas and weakness continued up until day 5. At day 5 8pm: loss of sensation in feet and legs, unable to ambulate, day 6: hospitalized for 7 days. Currently in inpatient acute rehab to re learn how to walk. Sharp painful neuropathy ongoing.
35 2021-01-21 numbness, facial paralysis The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home,... Read more
The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home, she noticed some numbness of her right face as well as drooping on her eyelids. The patient came back to the hospital where she received her vaccine and checked into the ED. Physician's differential included Bell's Palsy vs CVA/TIA. The patient was discharged with prednisone 20mg daily for 7 days.
35 2021-01-21 pain Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp ... Read more
Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp is 97.5), unable to sleep for over 2 days (still haven?t slept partly due to extreme pain), extreme pain all over body especially on left side, racing heart (103 while laying down normal resting is 78), fever would not go down with any amount of fever reducer for 2 days (starting to slowly go down), sore throat, swelling in ankles and feet for two days (is going down now), congested nose, severe ear pain, joint stiffness and extreme ache. Itchy all over body and rash on back. I received the vaccine on 1/20 it is now 1/22 and most are still present though some are getting better very slowly. I did not seek medical care as no one would see me so I just have isolated myself and checked in with a good friend regularly. I just felt it important to report this as no one warns how bad the reaction may be and unlike with the first dose, absolutely no check ins from hospital. I find that to be completely unacceptable.
35 2021-01-21 pain fever, chills, body aches, injection site soreness
35 2021-01-23 feeling hot, dizziness patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" .... Read more
patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" . Patient then went limp in chair. when called by name she woke up then lost consciousness. Patient was placed in a W/C brought into med room to lay down. pt awake and breathing VS taken. drinking water. Vs continued to be monitored . Patient states, " I am really lightheaded and do not feel well'. Rapid response called, patient taken to ER. on a gurney with 2 nurses. Husband was notified, and updated.
35 2021-01-24 dizziness 1/14/21 Developed aching to my left underarm/armpit area while at rest. Aching has been ongoing and... Read more
1/14/21 Developed aching to my left underarm/armpit area while at rest. Aching has been ongoing and intermittent. 1/17/21 Developed left ear "fullness". On 1/20/21 went to GYN for exam, explained left underarm pain, told that my breast exam appeared normal, but she questioned if my left ear fullness and left under arm pain were related. 1/21/21 Left Ear "fullness" began to radiated causing left temporal pressure, spreading across forehead. Pressure developed behind both eyes. Sudden onset of dizziness occurred. Went to urgent care where they said I had swollen lymph nodes and believed I was having a auto immune response to something. Told I received the vaccine on 1/7/21, they said the symptoms could be related to the vaccine. 1/22/21 Notice I would occasionally feel like I had a "lump or pressure" to the side of my throat. As of present I am continuing to have Left Ear "fullness", left underarm aching, and bilateral eye pressure has bee intermittent yet ongoing.
35 2021-01-24 pain Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up ... Read more
Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; This is a spontaneous report from a non contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. Medical history included Allergies, anxiety, depression. Concomitant medication included sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took minocycline and experienced drug hypersensitivity. The patient received 1st dose of bnt162b2 on 21Dec2020 10:00 AM Intramuscular at Left arm. The patient experienced Body aches, headache and fever up to 104.1 degrees taken orally. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
35 2021-01-24 dizziness, tremor Dizziness, chills and tremors.
35 2021-01-24 pain Headache, bone pain, fatigue, body aches were present when I woke Sunday morning I slept 28 hours an... Read more
Headache, bone pain, fatigue, body aches were present when I woke Sunday morning I slept 28 hours and awoke Monday morning still having a severe headache. Headache responds minimally to ibuprofen.
35 2021-01-24 numbness Numbness and swelling of the face, throat and hands. No difficulty breathing or swallowing, Denies p... Read more
Numbness and swelling of the face, throat and hands. No difficulty breathing or swallowing, Denies pain. Pt reports that symptoms are similar to covid illness in November.
35 2021-01-24 numbness, weakness Right facial numbness from cheek to jaw line. Weakness to jaw. Symptoms lasted 9 hrs and then reoc... Read more
Right facial numbness from cheek to jaw line. Weakness to jaw. Symptoms lasted 9 hrs and then reoccurred 9 days later.
35 2021-01-24 feeling hot Swelling, redness to about 1.5 inches by 1 inch. Warm to touch. Sometimes itches
35 2021-01-24 weakness, dizziness Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized... Read more
Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized pain and swelling at injection site
35 2021-01-24 numbness, tingling, feeling hot Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my lef... Read more
Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my left wrist up my arm to my neck. Then I felt like I had been hit in the head with a bat, but the pain migrated from side to side in my head. It was a very strange feeling. The hot, tingly numbness lasted about 45 minutes to an hour, the headache began to subside after 2 hours. The next day I had a little raised redness and the injection site and a bad headache, but was otherwise fine. At the vaccination site they strongly advised I go to the ER, which I did. I have no history of vaccine reaction.
35 2021-01-24 pain headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contact... Read more
headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contactable physician. This physician reported for a 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID on 10Jul2020 and 11 weeks of prolonged illness. The patient's concomitant medications were not reported. Patient with no significant risk factors except for a BMI of 34. On day 33 (13Aug2020) post diagnosis she was PCR and IgG positive. On 01Dec2020, patient had the first Pfizer Covid vaccine dose. The first 2-5 days (Dec2020) were described as very bad, fever to 101F, chills, headache, body aches, congestion. The week after she was somewhat better but didn't feel better until day 9 post vaccination. Outcome of the events was unknown. Information on the Lot/batch number has been requested.
35 2021-01-25 dizziness 10 min after injection became dizzy. BP 130/102, HR 105/107 SPO2 99%, T 97.7 Started taking Zoloft... Read more
10 min after injection became dizzy. BP 130/102, HR 105/107 SPO2 99%, T 97.7 Started taking Zoloft 50 mg QD 1.5 weeks ago Had COVID in Nov 2020 BP recheck 146/88, HR 98, Dizziness resolved @10:50AM
35 2021-01-25 pain Fever, Chills, body aches, fatigue, and headache
35 2021-01-25 dizziness First dose no effect. Went into second dose mildly dehydrated, went for a hike and at +6 hrs, myalgi... Read more
First dose no effect. Went into second dose mildly dehydrated, went for a hike and at +6 hrs, myalgias. At +12 hours mild anorexia, nausea, periorbital headache, myalgias. At +14 hours, fevers, throbbing headache, sweats, chills, arthralgia and myalgias, lightheadedness, dizziness, nausea with dry heaves. All symptoms subsided by 25 hours post- injection without residual effects at all.
35 2021-01-25 pain I developed significant joint pain in my knees approximately 3 days after my second COVID19 vaccinat... Read more
I developed significant joint pain in my knees approximately 3 days after my second COVID19 vaccination. I have no history of joint pain and have no recent changes in my activity level or medical history. Even walking as a casual pace causes pain. It is not severe enough to interfere with activities of daily living, but it is certainly noticeable. I cannot think of any other potential cause of this pain. The it has been approximately 4 days since this pain began, and it has not improved.
35 2021-01-25 feeling hot day 5 of the second shot I woke up extremely hot, felt like my skin And everything around me was bu... Read more
day 5 of the second shot I woke up extremely hot, felt like my skin And everything around me was burning/overheating; I also had mild hot flashes after the second vaccine and headaches; I also had mild hot flashes after the second vaccine and headaches; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included Asthma, hypothyroidism, ADD. Concomitant medications were not reported. Patient had known allergies to erythromycin and seasonal allergies. it was unknown if covid prior vaccination. There were other medications in two weeks. Patient used took first dose of BNT162B2 (lot number: Ej1685) on 17Dec2020 at left arm at single dose for COVID-19 immunization and experienced extreme episode of overheating (at night) the first time, got up and almost passed out. It was reported day 5 after both shots patient had an extreme episode of overheating (at night) the first time she got up and almost passed out. day 5 of the second shot she woke up extremely hot, felt like her skin and everything around her was burning, it was inescapable, she had to open a window and wait it out, lasted about 30 minutes. she also had mild hot flashes after the second vaccine and headaches. adverse event start date was 10Jan2021. No covid tested post vaccination. no treatment received for the events. Patient was recovering from the events.
35 2021-01-25 dizziness lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous re... Read more
lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering). Information on the lot/batch number has been requested.
35 2021-01-25 pain mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Sligh... Read more
mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Slight post nasal drip; cough; This is a spontaneous report from a contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:5730), intramuscular in left arm on12Jan2021 19:00 at single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin (PCN). Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously took Levaquin and versed and experienced allergies. The patient received the first dose of bnt162b2 (lot:5730) on 21Dec2020 at 18:30, intramuscularly in the right arm for covid-19 immunisation. On 12Jan2021 07:00, events started 12 hours of out with mild chills. Temp 99. Body aches. Took Tylenol 0900, symptoms improved to tolerable range. Temp spiked to 101 at 1500. Chills, body aches- especially back/ hips. Slight post nasal drip and cough. The outcome of the events was not recovered
35 2021-01-26 pain Beginning the morning after my second vaccine dose, I experienced body aches, joint pain, nausea, di... Read more
Beginning the morning after my second vaccine dose, I experienced body aches, joint pain, nausea, diarrhea and fatigue. By 24 hours post-vaccine, I developed a fever of 100.8, a headache, and swollen lymph nodes. By 36 hours, my fever broke, diarrhea discontinued, and the headache subsided. The body aches, nausea, fatigue, and swollen lymph nodes continue to inhibit my ability to perform ADLs and I was unable to work today.
35 2021-01-26 numbness, tingling Patient reported numbness and tingling following 2nd dose of vaccine. (also reported with 1st) Pati... Read more
Patient reported numbness and tingling following 2nd dose of vaccine. (also reported with 1st) Patient presented to the Emergency Department: 4 days following vaccination (1.24.21) with CHEST PAIN (Pt receive the 2nd dose of Covid Vaccine on Wednesday and since then she has had numbness/tingling and chest pressure. Hasn't been able to sleep and just feels funny. PT has HX of MS). Chest pressure started last night and is 5/10 in severity not reproducible on exam and not pleuritic. Vital signs stable at time of presentation. She is in moderate distress related to chest pressure. On exam she has diminished sensation on her entire right side of her body as well as numbness and tingling in her left hand. Discharge with instructions to follow-up with neurologist regarding numbness and tingling and to obtain MRA as planned
35 2021-01-26 pain Sharp pain with limited range of motion
35 2021-01-26 feeling cold Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headac... Read more
Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headache. Her BP was checked and was 206/110 using a wrist monitor... 142/96 using a manual BP apparatus and stethoscope after 30 mins... pt felt chills and was cold. Complained of nausea 5 mins before EMT arrived.
35 2021-01-26 pain body aches, chills, fatigue, and generalized headache vaginal bleeding that started 01/27/2021 (have... Read more
body aches, chills, fatigue, and generalized headache vaginal bleeding that started 01/27/2021 (have a Mirena and have not had menstrual bleeding in 3 + years)
35 2021-01-26 pain, swollen extremities injection site soreness (1/26/21 to current), axillary swelling on side of injection (1/26/21 to cur... Read more
injection site soreness (1/26/21 to current), axillary swelling on side of injection (1/26/21 to current), fever (1/26/21 to 1/27/21), body aching (1/26/21 to current), chills (1/26/21 to 1/27/21), intense fatigue (1/26/21 to current), feeling cognitively fuzzy (1/26/21 to current) awaiting resolution of fatigue, cognitive fuzziness, and axillary swelling no treatment at this time unless these symptoms do not resolve
35 2021-01-26 pain in extremity some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to peopl... Read more
some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people; Soreness in my arm; Headache; This is a spontaneous report from a contactable consumer reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. And right after the vaccine the patient was okay. Into the next day (07Jan2021) the patient had soreness in her arm, and headache which was known as a common side effect of the vaccination. But as of Monday, had been experiencing some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people. Because she was almost gag in. Every time she talked she felt like she was going to throw up just if she was upright she felt like she had to throw up. So, she reached out to her employee health services and they asked her to reach out to you guys. She just wanted to add that she didn't experience this portion right away, it took some days for her to feel this. No treatments received for the event nausea. Outcome of the event nausea was not recovered. Outcome of other events was unknown. information on the lot/batch number has been requested.
35 2021-01-26 pain in extremity upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's ... Read more
upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's a small lump present there; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Sore arm for 2 days after receiving vaccine/upper left arm feels sore; exposed to 2 COVID positive coworkers in the pharmacy; This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown (reported as "misplaced/discarded")), intramuscular (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included allergies: iodine and, postural orthostatic tachycardia. Concomitant medications included ergocalciferol (VITAMIN D); docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); probiotics NOS and; prenatal multivitamin. The patient was pregnant at the time of vaccination (last menstrual date: 05Dec2020, gestational period: 3 weeks, delivery date: 11Sep2021). The patient experienced sore arm for 2 days after receiving vaccine on 31Dec2020 (no treatment was received for this adverse event); no other side effects experienced. Then the patient was exposed to 2 COVID positive coworkers in the pharmacy on 31Dec2020, 02Jan2021, 03Jan2021, 04Jan2021, and 06Jan2021 (no treatment was received for this adverse event). The patient was informed about the exposure on 11Jan2021 and on the same day she had a PCR COVID test via nasal swab submitted. The test result came back on 12Jan2021 and it was negative. Today (13Jan2021 14:00), the patient stated that her upper left arm feels sore and tighter, it feels like there's a small lump present there (no treatment was received for these adverse events). The patient had no Covid prior to vaccination and had no other vaccine in four weeks. The outcome of the events was unknown. Information about the lot/batch number has been requested.
35 2021-01-28 pain Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat se... Read more
Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat seemed red; Sick; Feeling heavy with her chest. She went to the ER; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient (Daughter) received 2nd dose of BNT162B2 (COVID-19 Vaccine lot number: EK9231, Expiry date: Apr2021) on 16Jan2021 at single dose for covid-19 immunization. Medical history reported was She was positive, our whole family had COVID and we all came down which was about the same time which was 29Dec. Concomitant drug were not reported. Retired Nurse stated, "I am calling for my daughter. She received her 2nd vaccination yesterday morning and she had some side effects. Like about 6 o'clock this morning she came in, she came in 6:35, she came and woke me up and said that she felt some of the reaction she is having. She has nausea, she has slight temperature 99.7, fatigue. Just a general feeling of aches and pains. It does not seem like it's an emergency. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd. She works in a hospital, she got her 2nd dose of vaccine like I said yesterday morning. "Retired Nurse stated, "I am not sure causality. I mean it is not an emergency. She was feeling fine yesterday. We all are feeling better now. She had the vaccine and last night she said she had a sore throat when I looked at her throat. Her throat seemed red but there was no angioedema or anything like that, she went to sleep and she came in 'feeling really' (voice distortion) sick. So, I do not know. Did they have relapses from the COVID? I do not know." Treatment was "Tylenol." Like I had said that she was feeling heavy with her chest. She went to the ER. She was at her work. She went to the ER." "Probably close to 10 days ago, they did lab work I think they might have been looking for a clot. They did do some lab work at the hospital with unknown results." Outcome of the event was unknown. No follow-up attempts possible. No further information expected.
35 2021-01-28 feeling hot Patient reported feeling abrupt onset at about 5 minutes after injection of a sensation of 1/2 of he... Read more
Patient reported feeling abrupt onset at about 5 minutes after injection of a sensation of 1/2 of her head feeling hot like she was in a hot shower and a flushed feeling. No other sx that would suggest anaphylaxis. 40 minutes in while still experiencing above affected side ear was flushed. Given 50mg of benadryl at that time and all symptoms resolved by 65minutes
35 2021-01-28 nerve pain, numbness The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerv... Read more
The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerve pain, and numbness in my hands. Prescription anti-inflammatory helped.
35 2021-01-30 slurring hemiplegic migraine, blurry vision, slurred speech, high bp 140/103, l
35 2021-01-31 dizziness At 11:30am the next day after receiving the second dose, I became extremely fatigued and felt dizzy ... Read more
At 11:30am the next day after receiving the second dose, I became extremely fatigued and felt dizzy and very nauseous. On the morning of 1/31/21, I felt the exact same symptoms but this time the nausea led to vomiting.
35 2021-02-01 pain in extremity 1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down ... Read more
1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down arm 0830 nausea, vomiting 0900 fever, tylenol and ibuprofen 1300 afebrile 1/30/21 - current (2/1/21) increased fatigue, muscle aches, loss of appetite, swollen axillary lymph nodes have persisted
35 2021-02-01 pain For 10 days I experienced reynauds syndrome in my hands and feet. Terrible painful touch sensations ... Read more
For 10 days I experienced reynauds syndrome in my hands and feet. Terrible painful touch sensations as well. 8/10 pain. Then it resolved. I received my second dose yesterday. So far I just feel like every bone in my body hurts and I feel like I have rabdo.
35 2021-02-01 tingling Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection ... Read more
Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.
35 2021-02-02 pain, tingling, facial paralysis Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensati... Read more
Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensation in left side of the forehead / facial weakness; This is a spontaneous report from a contactable Physician reported for self. This 35-Year-old-female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 15Jan2021 08:20 on Arm left at single dose for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. None concomitant medication included. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 08:20 AM at the age of 35 year old via IM Injection Upper Left Arm for covid-19 immunisation, no reactions with first dose and flu vaccine, Expiry Date: Oct2020 for immunization and no reactions. The patient experienced Bell's palsy on 19Jan2021 and received prednisone 60 mg for 7 days. The same day of the vaccination (15Jan2021), she started to experience pain in the left side of her face, aggravated by 18Jan2021, her pain irradiated to ear and jaw. On Saturday 16 post vaccinated, she experienced also tingling sensation in left side of the forehead on 16Jan2021. She experienced facial weakness on 19Jan2021. And in 19Jan Monday evening Bells Palsy was confirmed. Lab data included Physical exams: weakness in the left side of forehead. No Covid tested post vaccination. Outcome of the event Bell's palsy was recovering. Outcome of other events was unknown. There was a reasonable possibility that the event Bell's palsy was related to BNT162B2. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-02-04 tingling, feeling hot, numbness, dizziness, feeling of body temperature change, tremor Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes ... Read more
Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in "icy hot," tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.
35 2021-02-16 vertigo, dizziness 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dos... Read more
4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; This is a spontaneous report from a contactable nurse (reporting for herself). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3302), at age 35 years, via an unspecified route of administration on the left arm, second dose on 29Jan2021, at single dose, for COVID-19 immunization. Medical history included breast feeding from an unknown date and unknown if ongoing, and COVID-19 on unspecified dates diagnosed prior to vaccination. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 08Jan2021 at age 35 years for COVID-19 immunization. On 02Feb2021, 4 days after the second dose, the patient experienced dizziness, nausea and was diagnosed with vertigo when seen in ER. The adverse event resulted in emergency room/department or urgent care visit. Treatment received for the adverse event includes IV fluids and meclizine. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The outcome of the event was recovering/resolving. Case was reported as non-serious.
35 2021-02-19 facial paralysis 2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeli... Read more
2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeling on left side of my tongue . As the day progressed I noticed my left side of face felt different number , my mouth was not opening wide on left side . I did a telemedicine call with a Dr that referee me to Er where I was diagnosed with Bell Palsy.
35 2021-02-21 numbness, tingling 3 days after first vaccine shot my thumb became a little numb and tingly and it eventually spread to... Read more
3 days after first vaccine shot my thumb became a little numb and tingly and it eventually spread to the 2nd and 3rd finger however no other side affects. When I went fir 2nd shot I asked pharmacist administering shot abs he said last time they may have hit a nerve I had no other side affects so I got second dose. Approximately 3/4 days after second dose on February right fingers became more numb and on 2/15 numbness started in left hand as well. Then on 2/19 started experiencing numbness weakness and tingling in both feet which progressively got worse so I went to the ER on 2/21. Blood work all came back normal and was sent home still having symptoms and told to see neurologist however still awaiting appt
35 2021-02-21 pain Chills, body aches, joint pain and fatigue.
35 2021-02-21 pain Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started... Read more
Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started same day and have lasted a week
35 2021-02-21 numbness Numbness on 1/2 of the face, left and drove home - resolved by the time she was home.
35 2021-02-21 pain Reported body aches, fever 100.6F, and headache. 1st dose administered on 1/28/21 Pfizer EL9262 / ... Read more
Reported body aches, fever 100.6F, and headache. 1st dose administered on 1/28/21 Pfizer EL9262 / 2nd dose administered on 2/18/21 Pfizer EN5318
35 2021-02-22 feeling hot Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also mor... Read more
Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also more tired than usual. Later that evening my injection site was sore, itchy, and raised, like a hive. On 2/23/21 I woke up at about 7:30AM and the injection site was the same as before, but I also had a sore/stiff neck and headache at the base of my skull. The reactions have not warranted a trip to the doctor, but I remember hearing somewhere that the CDC was interested to know about any side effects that may be related to the vaccine.
35 2021-02-22 dizziness Dizziness, vestibular neuritis, continuous since 1/20.
35 2021-02-22 dizziness pt w hx of vagal events with vaccinations and blood draws. shortly after vaccine administration, be... Read more
pt w hx of vagal events with vaccinations and blood draws. shortly after vaccine administration, became nauseated, pale, and dizzy. improved after 30 minutes.
35 2021-02-23 pain in extremity sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from ... Read more
sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
35 2021-02-24 feeling hot, pain in extremity Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a n... Read more
Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on her right arm, via an unspecified route of administration on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included thyroid condition and environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and levothyroxine. The patient experienced Chills, Arm Soreness, Malaise, slight sore throat, warm body feeling; all for 05Feb2021 10:00AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
35 2021-02-25 pain I had horrible body aches, chills, fever (100.8).It felt impossible for me to move around. I was in ... Read more
I had horrible body aches, chills, fever (100.8).It felt impossible for me to move around. I was in early stage of my pregnancy took a test on 1/7. My first doctor appt was 2/1 was told 8 weeks pregnant had a ultrasound didn't show any yoke or fetus. I had multiple ultrasounds done that week to enI had to have a DNC on 2/10 done and I'm still waiting on my DNA chromosomes to come back (plasenta show abnormality).(estimated date of delivery Pt stated around Sept 2021)
35 2021-03-02 pain, pain in extremity Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercisin... Read more
Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercising like I can't take a big enough breathe; Centralized chest pain on sternum.; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Arm soreness; Nauseous all week; loss of appetite; Sore to touch; heavy chested; medical history included Hashimoto's; medical history included Hashimoto's; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date not provided), via an unspecified route of administration on 25Jan2021 19:00 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included Hashimoto's, asthma, and food allergy all from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. The patient was not COVID tested post vaccination. Patient is not pregnant. Concomitant medications included levothyroxine sodium, liothyronine sodium, progesteron, and sertraline. Adverse events on 26Jan2021 at 07:00 were reported as follows: Centralized chest pain on sternum. Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak (patient reported that she has asthma). Sore to touch. Couldn't take a full breath, most intense standing or laying down, lesser when seated. Lasted just over 48 hours. Patient also stated, 'Still feel heavy chested when exercising like I can't take a big enough breathe'. Patient also reported arm soreness, nauseous all week, loss of appetite. Also on period. The patient has not received treatment for the events. Outcome of the events was reported as 'Recovered with lasting effects'.
35 2021-03-02 pain in extremity, lightheadedness had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walkin... Read more
had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-02 pain nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous re... Read more
nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on left arm on 16Feb2021 11:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypothyroid, Allergies to amoxicillin and sulfa drugs. Concomitant medication (received within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), buspirone hydrochloride (BUSPAR) and vitamin D. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 26Jan2021 at age of 35 years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced nausea - 6hrs post shot, headache - 10hrs, body aches and chills - 14hrs. The outcome of events was not recovered. No treatment received for the adverse events. All events reported as non-serious. No follow-up attempts are possible. No further information is expected.
35 2021-03-04 pain in extremity Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and s... Read more
Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and she usually has a heart rate in the 80s; shortness of breath; approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; Blood pressure increased; Clammy/cold sweat; muscle tenderness/all the muscles in her left arm were tender/aching; bruising near the injection site; she had bruising (more than usual) throughout the rest of her body; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; anxiety; This is a spontaneous report from a contactable consumer (patient/Registered Medical Assistant). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0142), via an unspecified route of administration on 12Jan2021 14:30 (2:30 PM) at single dose on left deltoid for COVID-19 immunization. Vaccination facility type is hospital. No history of previous immunization and no additional vaccines administered on same date of Pfizer suspect, also reported as "Prior Vaccinations (within 4 weeks): None". Medical history included ongoing Vitamin D deficiency for quite a few years. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) from Oct2020 and ongoing at 50000 IU gel cap, once weekly for Vitamin D deficiency. Patient is scheduled to receive the second dose of Pfizer vaccine on 02Feb2021 but reported side effects from her first shot including bruising near the injection site, shortness of breath, muscle tenderness and elevated heart rate (main concern). Upon contacting her HCP, she mentioned that this may be a side effect of her anxiety medications and asked "Should she take the second dose?". Approximately 22hours (13Jan2021) after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site. COVID-19 vaccine injection site became red, warm, and itchy, also experienced blood pressure increased, shortness of breath and Clammy, all on 13Jan2021. The patient was pale on 13Dec2020. Patient noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) that the lymph nodes in her left axillary (or armpit area) were swollen, and super tender (onset reported as "Jan2021"). Patient became sweaty on 14Jan2021. It was further reported that patient received her first COVID-19 Vaccine dose on 12Jan2021 2:30PM . She said after receiving the first COVID-19 Vaccine, she has had multiple symptoms. Patient is now due for her second COVID-19 Vaccine dose today 02Feb2021. Patient did not know if she should get the second COVID-19 Vaccine dose, and if her side effects were from the first COVID-19 Vaccine. Patient works in a doctor's office where there is a medical doctor, nurse practitioner, and several other registered medical assistants. Approximately 12 hours later after vaccine, at 2:30AM (13Jan2021), her left arm was extremely sore. She said she went to work on Wednesday, 13Jan2021, and her left arm was still really sore, but she was fine, otherwise. She said approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID- 19 Vaccine injection site. She said her COVID-19 Vaccine was given a lot higher than she thinks the vaccine should have been given. She said the COVID-19 Vaccine injection site became red, warm, and itchy. Her heart rate and blood pressure shot up, and she had pretty bad shortness of breath. Patient said that the medical doctor and nurse practitioner (where she works) told her she gave herself a panic attack. She said that the medical doctor, who she works for, told her to go home, and to contact her primary care doctor if she doesn't feel better. Patient left work and went home. Patient clarified her heart rate was in the 120s, and she usually has a heart rate in the 80s. She said she was pale and clammy, too. Patient stated that she went to bed when she got home from work on 13Jan2021, and woke up the next morning (Thursday, 14Jan2021), and got ready for work. She said as she was getting dressed for work, she felt her pulse rate go up, and she became sweaty, and clammy. She said she called her work, and her boss (medical doctor) told her to take some Tylenol and rest, and to call her primary care doctor if she was not feeling better. Patient said that her primary care doctor said she was having anxiety, and started her on medicine. She said the medicine helped, but her heart rate was still 112-115. She said she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender. She said all the muscles in her left arm were tender, as well. She said her left arm muscles were still aching. She said she had bruising on her left arm, and noticed she had bruising (more than usual) throughout the rest of her body. She said she has no idea if the bruising is a coincidence, or if the bruising is related to receiving the COVID-19 Vaccine. Patient mentioned that her left axillary lymph nodes were swollen for a good week and a half, but the swelling improved and was gone now. She said her heart rate was still elevated at 106-110 when she last checked her heart rate an hour and half ago. She said her heart rate was elevated, even though she was sitting down doing tele-work, and she has been taking anxiety medicine. She said she was still having breathing discomfort, clarifying she could not take a big enough breath. Patient will take a big breath, and will be good for a while, but then she needs to take another big breath. She said her doctor has checked her lungs, and her lungs were clear. She said she has to take multiple, deep breaths throughout the day. Patient's last blood work was in Oct2020. She said everything was good with her blood work. She said her hormones were good, but she had a Vitamin D deficiency. For treatment, patient stated that her primary care doctor prescribed Buspar 7.5mg, twice a day. She said the Buspar 7.5mg was dispensed in a pharmacy bottle and did not have the NCD, Lot, and Expiration Date. She said it will be 3 weeks from tomorrow (03Feb2021) she has been taking the Buspar 7.5mg and reported everyone seems to think she has anxiety, or she was crazy. Events did not require emergency room visit but patient visited physician office. There were no relevant tests. Outcome of muscles in her left arm were tender/aching, was not recovered, for axillary lymph nodes swelling and tender was recovered in 2021, for heart rate was elevated, Shortness of breath/breathing discomfort was recovering while for other events was unknown.
35 2021-03-04 dizziness, weakness Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 9... Read more
Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 97 RR 26 O2 98% BGM 129 at 1430. At 1440 146/95 HR 93 RR 18 O2 95%. EMT did not administer any medications, EKG Normal sinus. Fire department recommended patient to hospital as she was alone and driving herself. Fire department escorted patient to hospital via ambulance as a precaution at 1456.
35 2021-03-07 pain in extremity Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and c... Read more
Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe back muscle spasm 1 day after injection; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL1284), via an unspecified route of administration on left arm on 29Dec2020 at 11:30 (at the age of 35years) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe back muscle spasm 1 day after injection (30Dec2020). Severe right leg (thigh knee and calf) pain 7 days after vaccine (05Jan2021). There were no treatment given for the events. The events were considered non-serious by the patient as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The adverse events result in doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The COVID-19 test (nasal swab) on 12Jan2021 was negative. The outcome of the events was recovered for pain in extremity and arthralgia in 2021 and for muscle spasms on an unspecified date.
35 2021-03-09 bell's palsy Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthca... Read more
Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received the 2nd dose (at the age of 35-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL8982), via an unspecified route of administration on the left arm on 05Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient had no known allergies and medical history reported as none. There were no concomitant medications. The patient was not pregnant (including the time of vaccination). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL1283), via an unspecified route of administration on the left arm on 15Jan2021 09:30 (at the age of 35-year-old) for COVID-19 immunization. The patient developed Bell's Palsy (left side of face paralysis) on Friday afternoon 19Feb2021 (2 weeks after second dose of the vaccine). The patient went to the doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to the event (which was considered as serious disability or permanent damage). The emergency room (ER) doctor prescribed valacyclovir and prednisone. Outcome of the event was not recovered.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug cannot be excluded for the reported event Bell's Palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-10 dizziness lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contacta... Read more
lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contactable healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. During her 30-minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. Treatment included water and snacks. Follow-up response to treatment was excellent. Patient discharged (pending clarification), she was stable to go home and follow-up with PCP. Differential diagnosis reported as vaccine-related anxiety (include misc mental health) and systemic reaction (hypoglycemia, hypotension, generalized rash). Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-10 weakness, tremor was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passi... Read more
was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passing out remote in distant past; started to feel very strange/No hearing or vision loss, just a general strange and uncomfortable feeling.; deep dreaming, then awoke feeling poorly; deep dreaming, then awoke feeling poorly; shaking; chills; BNT162B2 used in a Breastfeeding Mother; BNT162B2 used in a Breastfeeding Mother; This is a spontaneous report from a contactable physician (patient), this physician reported information for both mother and fetus/baby. This is the maternal report. Only this case is serious. A 35-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular into left arm on 05Feb2021 09:00 at single dose for COVID-19 immunization in workplace clinic. Medical history included hx of passing out remote in distant past. No allergies to medications, food, or other products. concomitant medications were none (no other medications the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously took the first dose of BNT162B2 on unspecified date at single dose for covid-19 immunization. About 17 hours after vaccine, at 3am (06Feb2021 03:00), while up feeding her infant and sitting in a chair in the dark, she started to feel very strange, kind of like she was going to pass out (hx of passing out remote in distant past). No hearing or vision loss, just a general strange and uncomfortable feeling. Tried to call for help. Lost consciousness for a few seconds and had deep dreaming, then awoke feeling poorly. Set child back to bed, went to bed myself, had shaking chills for maybe 30 minutes following. No sweats, no normal symptoms related to vasovagal syncope. Just a general uncomfortable strange sensation as the prodrome. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovered from the events on unspecified date. It was reported as non-serious report. Seriousness criteria results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the Company considers the reported event loss of consciousness recurrence is unrelated to BNT162B2 vaccine but more likely an inter-current medical condition in this subject with medical history of passing out remote in distant past. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021240721 mother/baby case
35 2021-03-15 unresponsive to stimuli She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning o... Read more
She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300.
35 2021-03-15 pain in extremity Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a sp... Read more
Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a spontaneous report from a contactable Other Health Professional. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 03Jan2021 at 09:30am (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The patient had none medical history. The patients Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for an unspecified indication, start and stop date were not reported. The patients past drug included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 administered in Arm Left arm on 23Dec2020 at 09:30am(Batch/Lot Number: EK5730) as single dose for covid-19 immunisation. The patient experienced sore big toes on both feet, bruising under toenails and poor circulation on both big toes on 15Jan2021 at 20:00. The outcome of the events was not recovered.
35 2021-03-18 pain in extremity, seizure Sore arm for first few days. Woke up on day 5 feeling off. Had an aura start in the left side of v... Read more
Sore arm for first few days. Woke up on day 5 feeling off. Had an aura start in the left side of vision and thought it was just a migraine. Took migraine medication and 45 minutes later had a seizure. This is the first in my life.
35 2021-03-19 tingling Paresthesias, neuropathy
36 2021-01-01 dizziness Patient felt nauseated and dizzy; HR went from 48 (Normal for patient) up to 58 and remained at 58 u... Read more
Patient felt nauseated and dizzy; HR went from 48 (Normal for patient) up to 58 and remained at 58 until discharge; BP=80/42 and went up to 92/58 (normal for patient); patient given juice, water and crackers and stated she felt better; discharged with co-worker; alerted to contact ED with any excerbation of symptoms
36 2021-01-01 dizziness Received the COVID19 vaccine 2 weeks ago, and the next day started to have dizziness/lightheadedness... Read more
Received the COVID19 vaccine 2 weeks ago, and the next day started to have dizziness/lightheadedness and palpitations. It was the worst the first 2-3 days after the vaccine. It has improved somewhat, but is still not fully resolved and my improvement seems to have pleatued in the past few days. It is not debilitating nor a deterrent for me getting my 2nd dose, but I felt compelled to report my symptoms as I don't see dizziness and palpitations listed as a possible side effect.
36 2021-01-02 pain Fever. For 2 days Severe Body aches Headache
36 2021-01-03 nerve pain, numbness 12/24/2020 swollen right side lymph nodes under arm; felt "on fire" reduced burning sensation over t... Read more
12/24/2020 swollen right side lymph nodes under arm; felt "on fire" reduced burning sensation over time. Then 1/1/2021 patient got weakness in bilateral arms, felt "rubbery" ; left arm and neck lymph nodes swollen 1/3/2021 was seen in ER for full body numbness, prickly heat, like waves of it. Bilateral arm weakness; nerves feel "on fire". vomiting x 1 50 mg of Benadryl taken approximately 9 pm on 1/3/2021.
36 2021-01-03 weakness Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, ... Read more
Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, weakness
36 2021-01-03 swollen extremities, tenderness Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issu... Read more
Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issues with armpit or breast tissue. Needed to take Motrin/Tylenol for pain and swelling for two days after vaccination.
36 2021-01-03 pain in extremity Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was f... Read more
Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was flushed. At 0930, I developed hives on my neck, chest and arms. I immediately went back to the vaccination site (I was still in the hospital at work) and was administered 25mg oral Benadryl and monitored for 30 minutes. The hives resolved, but I still felt unwell. At 1600 I noticed a swelling in my right upper thigh about the size of my hand. It was about 2 inches inferior to my inguinal crease and was the width of my thigh. It was mildly painful to the touch. My injection site was red, inflamed and itchy. I continued taking 25-50mg Benadryl Q4 and took 100 mg at night due to itchiness on my eyes, face, neck, chest and arms. This is still present, although less each day, as of Monday 1/4/21 morning. I have felt feverish but have not had a recorded fever. I took some Ibuprofen for the pain in my arm at the injection site. The redness, swelling and itchiness has decreased each day at the injection site, but is also still present as of Monday 1/4/21 morning. I still feel unwell and have continued diarrhea throughout the weekend.
36 2021-01-03 vertigo, pain Sunday started with severe headache and continued with mild body aches and feeling of just being tir... Read more
Sunday started with severe headache and continued with mild body aches and feeling of just being tired but didn't change my day much. Woke Monday morning at 4am to get ready for the work and the room was spinning. Off and on for the next 4 or so hours my blood pressure dropped and I had to lay back down. Even laying down had the room spinning. It has not been consistent and has improved as the day has gone but has yet to go away.
36 2021-01-03 pain Temp 100.4,dry cough, headache, body aches, fatigue, runny nose started 1-2-20 started dexamethasone... Read more
Temp 100.4,dry cough, headache, body aches, fatigue, runny nose started 1-2-20 started dexamethasone, zpack Pepcid vit c vit d zinc aspirin
36 2021-01-04 dizziness Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands... Read more
Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands. Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
36 2021-01-04 weakness Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, los... Read more
Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, loss of strength, tenderness and inability to move arm.
36 2021-01-04 dizziness Complained of feeling lightheaded and dizzy
36 2021-01-04 pain Fever Body aches
36 2021-01-04 feeling hot, tremor I have learned that it was syncope. I felt like time was moving quickly. I was jittery and felt like... Read more
I have learned that it was syncope. I felt like time was moving quickly. I was jittery and felt like my heart was beating quickly. I was taken to a separate area and felt warm and flush in my chest. They laid me down on the cot and said I looked pale. My hands were cold and within minutes I was shaking uncontrollably. I think it was an anxiety related to my research I've done at my job related to COVID. I don't think it was an allergic reaction, but I do have an appt on Thursday. I was monitored for about an hour. Symptoms went away but I wasn't totally ok until the next day besides soreness in next arm.
36 2021-01-04 dizziness, pain in extremity, vertigo I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant ... Read more
I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly) back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
36 2021-01-04 pain in extremity, swollen extremities, tingling Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of b... Read more
Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of body. As evening progressed, patient reports worsening HA and vomiting. Pt reports pain in R arm and swelling in armpit area. Reports s/s resolved the next day. Recommended f/u with PCP.
36 2021-01-04 pain Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fev... Read more
Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via intramuscular route of administration in the left arm on 28Dec2020 at 08:00 AM (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 28Dec2020, the patient experienced vomiting, body aches and fever of 102. The report was reported as non-serious. The patient was not treated for vomiting, body aches and fever of 102. The clinical outcome of vomiting, body aches and fever of 102 was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 (rapid test nasal swab) on 31Dec2020 and was negative. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
36 2021-01-04 weakness, lethargy starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have b... Read more
starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.
36 2021-01-04 feeling hot, pain in extremity woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection si... Read more
woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history included ongoing high blood pressure. Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.
36 2021-01-05 lethargy, tingling, pain in extremity, pain, dizziness 40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching s... Read more
40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching sensation and mind pain in left arm and hand continued for a few hours then spread into left leg which continued into the next day. Moderate left shoulder tenderness 6 hours after shot lasting 2 days. 6 days after shot severe lethargy, body aches and brain fog which is current on 01/06/21.
36 2021-01-05 dizziness Chest pain, dizziness, lightheadedness
36 2021-01-05 dizziness Dizziness Narrative: Dizzy approximately 2-3 minutes after vaccine injection
36 2021-01-05 pain in extremity Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and f... Read more
Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and felt fine. Started to have a hot flash on the way home. Then her tongue felt sluggish but not swollen. She had a few minutes having difficulty swallowing but denies a sensation of throat swelling. Arm became sore and heavy but no redness. Drove back to the hospital with the onset of these symptoms and waited in the parking lot for 15 minutes to see if the symptoms were going to progress but they didn't. Stated she became very fatigues for a few hours but felt fine the next day except for a sore arm.
36 2021-01-05 pain Fever started around noon with body aches , chills, and a headache
36 2021-01-05 pain Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; T... Read more
Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; This is a spontaneous report from a contactable other HCP (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 30Dec2020 at 12:15 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included environmental allergies only. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced fever, head face pounding, heart rate up, body aches, headache, chills, tired, injection site pain; on 30Dec2020 at 06:00 PM. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
36 2021-01-05 pain I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery ey... Read more
I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery eyes; sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included fibromyalgia. The patient has no known allergies. Concomitant medications included an unspecified multivitamin, cyclobenzaprine, methylphenidate, sertraline and ibuprofen. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID prior vaccination. The vaccine was administered in a nursing home/senior living facility. On 01Jan2021, at 8:00 a.m., the patient experienced body ache, clear nasal drainage, nasal congestion, headache, moist cough, sneezing, watery eyes, and sore throat. The patient did not receive treatment for the events. The patient has not yet recovered from the events. The patient had a negative post vaccination polymerase chain reaction (PCR)/ nasal swab on 02Jan2021. Information on the lot/batch number has been requested.
36 2021-01-05 tingling, facial paralysis, feeling hot, pain in extremity I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very ti... Read more
I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very tired around 5pm. Around 6:30 I experience heat on the left side of my neck up to the back of my left ear. Also tingling, mild swelling, and drooping on left side of face that lasted a couple of hours. The next day I still experienced the heat feeling in left side of neck up to the back of left ear, fatigue, and soreness in arm. But by 3pm I felt fine and haven't had any problems since.
36 2021-01-05 migraine I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in ... Read more
I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in both fields of visions for 10 minutes followed by kaleidoscope vision in the left field for 5 mins. No headache after.
36 2021-01-05 pain in extremity, numbness, tingling On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness i... Read more
On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.
36 2021-01-05 weakness Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash fr... Read more
Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash from chest down it was a burning and itching and red spots. They took me to ER and gave me medicine. Within 40 mins I felt better so I left to go home. I have been feeling really tired and weak. I went home on the 4th with weakness and I did vomit 1 time. I felt sick to my stomach all day. I came back to work today still feeling nausiated."
36 2021-01-05 pain, dizziness The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body ... Read more
The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body aches, diarrhea, vomiting, productive cough, and profuse sweating. Jan 1st I was in the shower and was dizzy with a headache. Loss of consciousness almost happened and that is when i got out of the shower and laid down. Went to the ED and was diagnosed with bilateral pneumonia
36 2021-01-05 pain in extremity, pain Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint p... Read more
Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint pains, sore throat, cough, swollen lymph nodes, and now a facial rash.
36 2021-01-06 dizziness 36F w/ Hx of HTN w/ HA and dizziness following COVID vaccine dose today. Symptoms began about 7 min... Read more
36F w/ Hx of HTN w/ HA and dizziness following COVID vaccine dose today. Symptoms began about 7 minutes post vaccination, no airway complaints, vomiting/nausea/abdominal pain, no chest pain, wheezing or SOB, no rash. VS wnl throughout course of observation in vaccine POD. Airway intact, no stridor, no signs of respiratory distress. Given PO fluids. Symptoms persisted resulting in transfer to Emergency Department for further evaluation and monitoring. Did not require additional interventions or any medications while in vaccine POD.
36 2021-01-06 pain C/o aches, chills, headache and fever that began the next morning at 6:00 am after receiving the va... Read more
C/o aches, chills, headache and fever that began the next morning at 6:00 am after receiving the vaccine. Treatment include Advil.
36 2021-01-06 pain Fever 101.3 with severe body aches and terrible headache since last night until now. It has been mo... Read more
Fever 101.3 with severe body aches and terrible headache since last night until now. It has been more than 24hrs since I received a vaccine.
36 2021-01-06 tremor Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headac... Read more
Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headache, nausea. I had redness and soreness at site of injection. Symptoms resolved within 24hrs with help from Tylenol.
36 2021-01-06 dizziness, feeling hot Immediately after injection, I felt a warm feeling flow from the injection site and across my chest.... Read more
Immediately after injection, I felt a warm feeling flow from the injection site and across my chest. No shortness of breath or chest pain. Felt slightly light-headed. Drank water and ate some food to closely monitor. Very sore Left deltoid starting about 8 PM on 12/31/20 (same day as the vaccine administration). It was so sore that it woke me up a few times at night and 1/1/21 I had to take Ibuprofen 400 mg to alleviate the pain. Had a dull headache all day 1/1/21 and very tired. Slept that night from 9 pm - 8 am next day. No symptoms since 1/3/21.
36 2021-01-06 tingling, dizziness Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from v... Read more
Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from vax site. Improved but still with lightheadedness and rash of upper chest. Given IVF and benadryl injx. Observation x 3 hours.
36 2021-01-06 tingling, numbness Pt reports numbness/tingling in hand and fingers on the right. Pt received 2nd dose of COVID-19 in r... Read more
Pt reports numbness/tingling in hand and fingers on the right. Pt received 2nd dose of COVID-19 in right upper arm approximately 5 minutes prior to time of RRT. Observed pt from 1146 to 1205. Pt maintained stable vital signs throughout observation period, maintained a strong regular pulse ranging from 80 - 90 bpm. Maintained oxygen saturation on room air between 98-100%. At time of release, pt was still exhibiting numbness in fingers and palm of right hand. Good range of motion with right arm. Denies any symptoms other than the above stated. Provided pt of option to be seen in the emergency department, but pt declined, and stated that she would like to wait and if her symptoms persisted or worsened, she would come back to the ER.
36 2021-01-06 facial paralysis transient right sided facial droop lasting 2-3 seconds 4 days after COVID-19 shot #1 of 2
36 2021-01-07 pain in extremity - Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along w... Read more
- Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along with feelings of mild illness (like a cold) and arm pain which is consistent with other vaccination response. - Waited at clinic for 30 minutes as directed due to previous history of anaphylaxis to injected meds (among others). Reported feeling poorly to nurse monitoring people waiting at 30 minute mark, who encouraged waiting longer but did no further assessment. Waited another 15 minutes with no resolution or improvement. Decided to leave and monitoring staff said they could not keep patients if they wanted to leave. - Approximately 15 minutes later (1hr after injection), took one 25mg Benadryl liquid gel as nausea/headache/fast heart rate were consistent with prior allergic reaction and not with prior vaccine response. Those symptoms resolved after 1-2 hours; the feeling of mild illness lingered for approx. 3 days more.
36 2021-01-07 numbness Approx 10-15 min post vaccine, pt began to c/o bilat foot numbness & flushing. NIBP 172/30, HR 90s. ... Read more
Approx 10-15 min post vaccine, pt began to c/o bilat foot numbness & flushing. NIBP 172/30, HR 90s. Benadryl 50 given IM. Pt discharged to ED, NIBP 157/111 HR 102.
36 2021-01-07 numbness, tingling Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/9... Read more
Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/90, HR 90s. No SOB, hypoxia. Benadryl 50 IM given @ 1756. Pt discharged from vaccine clinic to ED. NIBP 157/111, HR 102 @ time of discharge.
36 2021-01-07 migraine Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my th... Read more
Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my throat was closing and I was choking; I had chest pain, chest tightness; I had chest pain, chest tightness; Very SOB at rest; Throughout the day I was cough and my face started flushing so I tool Benadryl/severe facial flushing; On 23Dec I got nerve blocks for my migraines.; Throughout the day I was cough and my face started flushing so I tool Benadryl.; This is a spontaneous report from a contactable nurse who reported for herself. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730) dose number 1, via an unspecified route of administration on 19Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included von willebrand's disease, narcolepsy with cataplexy, IIH (Idiopathic intracranial hypertension), HTN (hypertension), GERD (gastrooesophageal reflux disease), migraines. Patient also had known allergies: PCN (penicillin), shellfish, IV contrast, cefdinir and bees. On 23Dec2020, patient got nerve blocks for her migraines. Throughout the day patient was cough and her face started flushing so she tooled diphenhydramine hydrochloride (BENADRYL). Around 22:30, patient felt like her throat was closing and she was choking. She had chest pain, chest tightness. EMS (emergency medical services) was called and patient was brought to the hospital. On 25Dec2020, patient felt like her throat was closing, like someone was sitting on her chest and chest tightness still with chest pain. Very SOB (shortness of breath) at rest. Patient went to the ER (emergency room) and received IV dexamethasone (DECADRON) and diphenhydramine hydrochloride. On 26Dec2020, patient had the same symptoms but with severe facial flushing and patient went back to the ER and was given IV dexamethasone. Patient was sent home on a maximum amount of medications. I had seen her primary care, ENT (ear nose throat centre), Allergy, ID (infectious disease), and pulmonology. Her CT (computerised tomogram) of chest on 25Dec2020 was negative along with her COVID test. Patient SOB on rest and exertion still. Onset date of the adverse events was reported as 23Dec2020, 22:30. Patient received treatment for the events included multiple medications and high dose prednisone. Lab data on 25Dec2020 included CT of chest: negative, influenza type A/B combo: negative, Covid 19: negative and nasal swab: negative. Action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. The clinical presentation of the events is suggestive of possible allergic reactions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-07 dizziness, pain, numbness Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours; light headed; numbnes... Read more
Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours; light headed; numbness in left hand and fingers from arm swelling; numbness in left hand and fingers from arm swelling; nausea; chills; headache; body aches; joint pain; first dose on 16Dec2020 10:15, second dose on 04Jan2021 11:45; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, first dose on 16Dec2020 10:15, second dose on 04Jan2021 11:45 (lot number EJ1685), both on left arm at single dose for COVID-19 immunization. Medical history included known allergies Sulfa. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours, light headed, numbness in left hand and fingers from arm swelling, nausea, chills, headache, body aches and joint pain on 04Jan2021 14:30. Patient received Acetaminophen and ibuprofen for treatment. The outcome of the events was not recovered.
36 2021-01-07 pain Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to... Read more
Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to monitor
36 2021-01-07 pain Heart palpitations, headache, body aches for 48 hours after receiving shot
36 2021-01-07 dizziness Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another ... Read more
Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another patient to get help. When staff arrived she was grey, dizzy, having difficulty breathing with rapid respirations and overall not feeling well. Pulse Ox was 88 on room air so she was placed on oxygen and the EpiPen was used. EMS was called. She began improving with the oxygen and after the 0.3mg of Epi. EMS transported her to the ER and at her request her boyfriend was notified.
36 2021-01-07 tingling, numbness Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptom... Read more
Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptoms responded rapidly. No complaints of GI, respiratory, cardiovascular symptoms. Observed almost an hour and a half.
36 2021-01-07 feeling hot, dizziness Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ... Read more
Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ice pack and cold cloths. BP was slightly elevated. Pulse initially was about 112. Had patient lay down and she felt better. Thought to be vasovagal response. Starting at 01:30 on 1/7/21 she had a severe headaches, eyes watering, runny nose, dry throat. Injection site reaction
36 2021-01-07 dizziness, pain Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after rec... Read more
Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after receiving the vaccine I became dizzy and lightheaded. I let the nurse in the observation area know and honestly didn't think much of it. It lasted about a minute or two. I was fine for several hours after just experienced the normal soreness and kind of achy tired feeling. Around 1700 I began to itch, my whole right arm and upper torso area was itchy. I did not take any medications for this and it subsided around 2000.
36 2021-01-07 tingling Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine... Read more
Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine. Observed and discharged.
36 2021-01-07 pain in extremity, pain headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that... Read more
headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name. She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
36 2021-01-07 numbness, tingling numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no... Read more
numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no drooping to face hives injection site pain
36 2021-01-07 pain in extremity sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by feve... Read more
sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.
36 2021-01-07 pain soreness at injection site, fatigue, chills, body aches, joint pain
36 2021-01-07 nerve pain vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; ... Read more
vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin "ito" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and "it appeared patient have eye shadow" was not recovered. Information on the lot/ batch number has been requested.
36 2021-01-08 feeling cold !2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, swea... Read more
!2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, sweats, diaphoretic / pale clammy skin, fever, and joint pain. all the fore mentioned symptoms were not all at once, every half hour and not all once. some symptoms lingered longer than others.
36 2021-01-08 pain in extremity, pain 1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: seve... Read more
1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: severe chills, worsening headache and neck pain, temperature started to rise, muscle and joint aches began 0500 - chills and aches continued, temperature max of 102.2 0800 - severe muscle aches, fever remained around 102, pulse 130's, SO2 99% 0900-2100 - rested the entire day, unable to move much because my body aches were so severe, when I did get up to go to the bathroom, I could barely walk because my hips and knees hurt so much, headache so severe that I began getting nauseous and dry heaving, I took 650mg acetaminophen and 25mg Benadryl around noon and used ice packs on my neck and the back of my head, ate very little, no appetite, drank water and ginger ale, temperature fluctuated between 101 and 102 all day, came down to 99.6 after acetaminophen, but came right back up to 101 as it wore off 2200 - took 975mg Tylenol and 25mg Benadryl and went to sleep, temperature 100.9 1/9/21 - 0900 - woke up after sleeping all night, temperature 98.2, body aches and headache gone, feel normal
36 2021-01-08 numbness, tingling 25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to loc... Read more
25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to location of vaccination site) with associated moderate headache. No tongue swelling or weakness. No breathing difficulty. This was followed by left arm numbness and mild left leg numbness. Left-sided paresthesias /numbness resolved within 3 hours of vaccination. The severity was mild-moderate without there ever being complete loss of sensation. No vision problems or weakness.
36 2021-01-08 dizziness Dizziness Narrative: Dizzy approximately 2-3 minutes after vaccine injection
36 2021-01-08 numbness, dizziness, pain, pain in extremity, tingling, lightheadedness Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of ap... Read more
Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of appetite, fatigue, abdominal pain, dizziness, near syncope, headache, insomnia, arm soreness, tingling and numbness in my face and mouth about 10 hours after dose and lasting about 30 min, taking ibuprofen one tablet q6 hours for fever and pain. 26 hours dose symptoms are improving
36 2021-01-08 pain Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe s... Read more
Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe symptoms started 1/7-1/8, worsened 1/9. Had close contact with two children and husband, but none have any symptoms.
36 2021-01-08 dizziness Probably with in 30 sec of the vaccine being administered I started to not feel well. Felt like it s... Read more
Probably with in 30 sec of the vaccine being administered I started to not feel well. Felt like it spread through my body, I felt a weird feeling in my chest, throat, my legs felt weak, I was light headed and my heart started to beat hard and fast. It then started to subside over several minutes. The nurse kept me for 30 minutes and then I felt ok to walk out. I had a bit of a headache and didn?t feel right the rest of the night.
36 2021-01-09 bell's palsy, facial paralysis Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swell... Read more
Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swelling
36 2021-01-09 pain in extremity, pain Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of inje... Read more
Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of injection, severe and with back pain upon waking on 1/5. By noon of 1/5, had all symptoms listed above. Continued worsening until I took Motrin 400 mg at 6:00pm. Symptoms improved significantly within 30 minutes, fever resolved. Body aches and sore arm persisted at mild levels for a few days but resolved by 1/8.
36 2021-01-09 pain Fever, body aches, joint land bone pain, headache. Improved with antipyretics and sleep. This occurr... Read more
Fever, body aches, joint land bone pain, headache. Improved with antipyretics and sleep. This occurred in the evening, so I?m not sure how long symptoms would have lasted as I went to sleep. I woke up feeling just slight tired and sore.
36 2021-01-09 vertigo, pain in extremity Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen fo... Read more
Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen for the headache and slept off all the symptoms
36 2021-01-09 pain in extremity, pain, lethargy Lethargy, Headache, Sore arm, Body aches for 36 hours
36 2021-01-09 pain Pain at site of injection, extreme headache, extreme body pain
36 2021-01-09 tingling, dizziness Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getti... Read more
Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getting ready for work. As I was walking to my kitchen, I suddenly became very dizzy with blurred vision, tingling hands, nausea, ringing in my ears, and I felt like I was going to lose control of my bowels. I became very weak in the legs and I made it to the couch before I fell. Episode lasted approximately 2 minutes. As I laid down, my symptoms recovered. My husband gave me some juice and toast. After about 20 minutes, I got up and was able to walk without symptoms. I felt perfectly normal prior to this event. Last night, I ate a full dinner and drank about a liter of water. This event did not seem to be precipitated by hypoglycemia or dehydration. For the rest of this day, I have felt normal.
36 2021-01-09 dizziness, tingling Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, t... Read more
Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, tachycardia, hypertension.
36 2021-01-09 pain low grade fever, chills, body aches (neck and back), fatigue, headache.
36 2021-01-10 pain 12 hours after receiving the shot I came down with chills, fever, and body aches. I had three bouts ... Read more
12 hours after receiving the shot I came down with chills, fever, and body aches. I had three bouts of this over the next 24 hours. The second one had a spike in fever just over 101. I monitored my symptoms closely and used Tylenol as recommended.
36 2021-01-10 pain Chills and sweats, aches beginning during sleep Nausea and Vomiting and diarrhea persisted until abo... Read more
Chills and sweats, aches beginning during sleep Nausea and Vomiting and diarrhea persisted until about 8am next day Next day fatigue and lack of appetite, resolved within 24 hours with slight residual Epigastric pain
36 2021-01-10 pain Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will c... Read more
Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will continue to monitor
36 2021-01-10 pain Chills, body aches, fatigue, lower back pain, eye pain. No treatment with minor improvement
36 2021-01-10 dizziness DIZZY LIGHTHEADED , FEELING LIKE PASSING OUT, HEART RACING.
36 2021-01-10 pain Diarrhea and body aches 3 days after vaccine. Full body aches 4 days after vaccine.
36 2021-01-10 numbness, dizziness Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later th... Read more
Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later that morning around 1130 had palpitations, dizziness, lightheaded ness that would not go away even when sitting down. I felt numbness around my mouth took blood pressure and it was elevated 200 systolic and 100 systolic called EMS they assessed my blood pressure but it was normal systolic 130?s which is hi for me Norma blood pressure for me 90-100 systolic
36 2021-01-10 tingling, pain, dizziness Headache, body aches, chills, fatigue, dizziness, confusion, extremity tingling in first 24 hours. A... Read more
Headache, body aches, chills, fatigue, dizziness, confusion, extremity tingling in first 24 hours. At 26 hours post injection, severe left axillary lymphadenopathy noted with axillary pain.
36 2021-01-10 migraine I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 day... Read more
I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 days after a migraine.
36 2021-01-10 pain, tenderness Lump found above left collarbone. Painful, tender to touch. Have an appt with my PCP 1/13 to be ass... Read more
Lump found above left collarbone. Painful, tender to touch. Have an appt with my PCP 1/13 to be assessed.
36 2021-01-10 dizziness Patient reported prior to vaccination hx of anaphylaxis to shellfish and macrobid. She was a 30 min... Read more
Patient reported prior to vaccination hx of anaphylaxis to shellfish and macrobid. She was a 30 minute post-vaccine nurse monitoring. ~15 minutes after receiving vaccination, patient reported to the nurse dizziness, nausea. Nurse placed patient on stretching and called for provider assistance. SBP in 160s, DBP >100, HR 130s or higher, oxygen saturation on room air ~98%. Epinephrine 0.3mg IM administered. Nurse placed Nasal cannula oxygen with oxygen saturation 100%. Patient BP improved, HR improved to low 100s occasionally in 110s if patient talking to someone new such as Fire response. Patient reported continued dizziness. BP prior to EMS arrival 146/91 left arm automatic cuff, Temp 98.3F, P 106, oxygen on nasal cannula 100%. Upon EMS arrival, patient transferred to ER.
36 2021-01-10 dizziness Patient reported, "I received my Covid 19 vaccination on Monday evening. I experienced a reaction im... Read more
Patient reported, "I received my Covid 19 vaccination on Monday evening. I experienced a reaction immediately following. Within 10 minutes I had tachycardia (130s), high BP (160s), lightheadedness, nausea, headache, and feeling like I was going to faint. I was attended to by Ambulance paramedics. At the time of her report to her primary care provider on 1/7/2021, she was still having pretty significant side effects (headache, dizziness, and light sensitivity), enough so that I was staying home from work. These symptoms have now resolved.
36 2021-01-10 tingling, pain, numbness Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull thr... Read more
Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull throbbing in jaw, pain in shoulder blade/back area towards left side--all of these symptoms progressively worsened and it is currently day 5 and still in a lot of pain, facial numbness/tingling for first two days on left side.
36 2021-01-10 weakness eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; ... Read more
eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-10 restlessness headache, nausea, acid reflux, joint and muscle aches, nausea, malaise, fatigue, restlessness
36 2021-01-10 tingling tingling to neck PO oral Benadryl 25 mg given
36 2021-01-10 pain in extremity tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt st... Read more
tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020. The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-01-11 numbness, tingling, dizziness Began having numbess to face, tingling to hands and legs and dizziness that started roughly 6 hours... Read more
Began having numbess to face, tingling to hands and legs and dizziness that started roughly 6 hours after injection; felt dizzy with movement and that her legs were going to give out.
36 2021-01-11 weakness Day 0: Patient developed fatigue, headache, weakness, muscle aches. Describes muscle weakness as m... Read more
Day 0: Patient developed fatigue, headache, weakness, muscle aches. Describes muscle weakness as mostly in her legs, feeling like they are going to give out. Grip strength normal. No difficulty breathing. Pain in neck and back similar to pain she experiences with ankylosing spondalitis. No numbness or tingling in hands and feet. Day 8: COVID test done - negative. No other tests run. Day 10: COVID PCR test done - also negative. No other tests run. Spoke with rheumatologist who believes it could be related to AS. Day 15: Still experiencing side effects - very fatigued. This is the first day she has been out of bed for more than a few hours at a time. Planned visit with PCP tomorrow.
36 2021-01-11 pain, tingling Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined ... Read more
Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined MD assessment (and states this resolved within hours. Day after shot (1/9), she states she noted redness/tenderness at site, fatigue, body aches, fever to 103 (responsive to tylenol; reduced to 99.4 after 8hrs). She presents to AOH 01/12/21 for assessment of L deltoid: 8x8.5cm injection site erythema/tenderness/very mild induration. States fever has resolved; neck/back aches continue; tenderness at site continues. Possible cellulitis? Advised to seek PCP counsel as soon as possible.
36 2021-01-11 dizziness Dizziness, vomiting, headache, and nausea
36 2021-01-11 pain Fever (101), intense body aches, fatigue, joint pain
36 2021-01-11 pain in extremity Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the ... Read more
Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the vaccine, she sees gray cloud-like vision, intermittently, usually gets worse during the afternoon.
36 2021-01-11 pain In 2015 I developed vulvar ulcerations (approximately 5), periorbital edema, and sensorineuroal hear... Read more
In 2015 I developed vulvar ulcerations (approximately 5), periorbital edema, and sensorineuroal hearing loss following vaccination with Td, Hep A, Menactra, Yellow fever and typhoid vaccines. This was previously submitted as a VAERS. I was treated with high dose steroids with partial restoration of my hearing. I had these issues extensively worked up by GYN, ENT and Rheumatology. Since that time I have had spontaneous vulvar ulceration (typically 1 lesion) on 3 occasions over the past 5 years with no preceeding infections or clear triggers. Approximately 36h after second COVID vaccination I began to develop vulvar ulcerations--currently have 4 -5 lesions. I also had body aches.
36 2021-01-11 tenderness, tingling, weakness Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness a... Read more
Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness and tingling in entire left side. I found it difficult to ambulate and lift my arm at all. This was followed by malaise, weakness, and fatigue. The decreased strength and sensation on the left side of my body lasted for several hours, gradually fading around 4am. The weakness of the left side of the body improved over time and I was just left with fatigue and malaise.
36 2021-01-11 pain, feeling hot Low grade fever, body aches, chills, nausea/motion sickness on Saturday. Sunday to Tuesday: nausea a... Read more
Low grade fever, body aches, chills, nausea/motion sickness on Saturday. Sunday to Tuesday: nausea and difficulty cooling down/sweating present
36 2021-01-11 pain Malaise, aches, headache, nausea, fatigue
36 2021-01-11 dizziness Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as fe... Read more
Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as feeling dizzy/lightheaded, also reports tingly lips. Patient stayed for observation for 30 minutes, once complete, reported still feeling slightly dizzy/lightheaded, but this is a normal reaction for her to vaccines per patient. Offered patient juice, and patient felt OK to leave, no medications given.
36 2021-01-11 restlessness Patient reported 2 hours after receiving the vaccine that she had a red spot on chest, took benadryl... Read more
Patient reported 2 hours after receiving the vaccine that she had a red spot on chest, took benadryl and zyrtec. Patient reported 30 hours after vaccine that rash had spread to whole chest, back, arms, and injection site and was hive like. Reports also having vivid and crazy dreams, feeling restless the night before.
36 2021-01-11 tingling Patient states that she received her second vaccination and in the hours after she had flu-like symp... Read more
Patient states that she received her second vaccination and in the hours after she had flu-like symptoms. Then over the next few days, she started to notice tingling and a "prickly" sensation in various areas. This progressed to symmetric BLE weakness which started in her feet and had reached to just above her knees bilaterally time and she arrived. The weakness had progressed to her hips. She also noticed weakness in her arms and they are easily fatigued. She is able to walk but it takes much effort.
36 2021-01-11 tremor, pain Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable ... Read more
Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable to sleep due to Such severe pain all over head to toe, chills/shaking , vomiting and sweats. As of now today 1/12 1pm still very achey and fatigued with waves of nausea.
36 2021-01-11 migraine, numbness, tingling Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and sore... Read more
Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and soreness around injection site. On 1/9- had a severe migraine was unable to get out of bed due to migraine and extreme light sensitivity. Experienced severe muscle aches and chills. 1/10- started experiencing facial swelling especially of the left side. Extreme left eye swelling. With headache. Went to ER. Was given Benadryl to reduce swelling fluids and Prilosec for throat irritation. 1/11-started experiencing left arm numbness and tingling radiating down to fingertips. Experience left side facial numbness and tingling. 1/12- symptoms have begun to improve.
36 2021-01-11 pain in extremity Right arm pain (injection site), nausea, chills
36 2021-01-11 weakness, dizziness Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering... Read more
Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
36 2021-01-11 pain Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up arou... Read more
Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
36 2021-01-11 dizziness Vaccine administered at approx. 9 am. At 1000am , began feeling very tired, dizzy. S/sx increased ov... Read more
Vaccine administered at approx. 9 am. At 1000am , began feeling very tired, dizzy. S/sx increased over the next 2 hours. - began vomiting, felt very "slow motion". At approx. 1 pm, went back to vaccine area; felt like there was more effort to breath (heaviness); given epi-pen in ED, S/sx improved, Hydration started.
36 2021-01-11 numbness, tingling Within 15 minutes of receiving the vaccine she developed jaw tingling. This resolved but when drivi... Read more
Within 15 minutes of receiving the vaccine she developed jaw tingling. This resolved but when driving home she developed jaw numbness which persisted over the next day. Eventually improved. Was recommended to proceed to the ED but she did not go.
36 2021-01-11 pain, weakness, pain in extremity around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body... Read more
around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body aches all over, and severe headache, around 3am had nausea to the point of needing zofran, chills continued until around 5am, body aches continued and was yelling, crying and tossing and turning, woke up at around 8am with 9/10 headache, light and sound sensitivity, alleviated some with coffee, extremely fatigued and weak (had trouble walking half a block), headache mostly gone by. 10am, fatigue continued throughout the day, NO appetite, intermittent chills. At bedtime ~9pm day 2 temperature 99.8. Slept through night. Sunday fatigue and excercise intolerance (typically exercise daily and am in good physical shape), had to sit down during walks with dog, Monday fatigue continued as did difficulty exercising long periods of time until afternoon, continued difficulty monitoring body temperature, getting cold really easily. Tuesday (today) continued weakness and exhausted but can't nap, no appetite. Never took anything except zofran 2x for nausea
36 2021-01-11 dizziness, tingling, numbness began having numbness to face, tingling to hands and legs and dizziness with movement and that her l... Read more
began having numbness to face, tingling to hands and legs and dizziness with movement and that her legs were going to give out
36 2021-01-11 pain in extremity, pain is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a cont... Read more
is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a contactable other health professional (patient). This reporter reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old female patient (pregnant) receive first dose of BNT162B2, via an unspecified route of administration on 04Jan2021 16:45 in right arm at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced extremely sore arm, body aches, headache on 04Jan2021. The adverse event was not resulted in emergency room visit and physician office visit. The events were reported as non-serious. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. Last menstrual date was 12Jun2020. The mother was 29 weeks pregnant at the onset of the event. The mother was due to deliver on 19Mar2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prenatal vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Allergies to medications, food, or other products was no. The outcome of events was resolving. Information on the Lot/batch number has been requested.
36 2021-01-11 pain, weakness it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized w... Read more
it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade. The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
36 2021-01-11 numbness left sided facial numbness left sided numbness on the hand; This is a spontaneous report from a cont... Read more
left sided facial numbness left sided numbness on the hand; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Jan2021 08:00 (lot number: EL1284) for the second dose and on 17Dec2020 08:00 (lot number: EH9899) for the first dose, both via intramuscular route in the left arm for COVID-19 immunization. Medical history included asthma and allergies to shellfish. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced left sided facial numbness and left sided numbness on the hand on 07Jan2021 08:30 with outcome of not recovered. The event was reported as non-serious with no treatment received.
36 2021-01-12 pain Body aches, chills, fever, fatigue. Treatment include Tylenol and Motrin. Fever resolved
36 2021-01-12 migraine, dizziness Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness... Read more
Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat. She has also noted episodic throat tightness and SOB in the 10 days since the vaccine. She has a history of anaphylaxis w/ morphine. She has an autoimmune condition currently being evaluated by rheumatology. Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose.
36 2021-01-12 pain, pain in extremity I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body ... Read more
I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body aches; Chills; This is a spontaneous report from a contactable nurse reporting for self. A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK923, via an unspecified route of administration on 05Jan2021 08:45 as a single dose (dose 1), left arm (age at vaccination: 36 years old), for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no other vaccine administered in the 4 weeks prior to the COVID vaccine. Medical history included multiple sclerosis and hypothyroidism . The patient was receiving unspecified concomitant medications ("10 meds").The patient previously took copaxone and experienced drug allergy. The patient reported having a sore arm, but also had been having a low-grade fever. The highest it had been was 99.5. The patient also had body aches and chills. These symptoms started couple hours after the injection (on 05Jan2021) and have been with the patient since then. The events were reported as non-serious. There was no hospitalization or treatment received for the events. The outcome of the events sore arm, low grade fever, body aches, and chills was not recovered. The patient had not been COVID-19 tested post vaccination.
36 2021-01-12 pain in extremity Intense bone/joint pain that occurred ~8 hours after vaccine. Started in hips/back, then moved to e... Read more
Intense bone/joint pain that occurred ~8 hours after vaccine. Started in hips/back, then moved to extremities. Patient unable to walk normally due to pain. Took 500 mg of acetaminophen at bedtime. Symptoms resolved the next morning except for slight right knee pain, which resolved by the afternoon. Patient feels that joints "crack" more frequently after vaccine.
36 2021-01-12 pain Note: I am currently breastfeeding. Had body aches; chills; fever of 102.6; headache; nausea; cough;... Read more
Note: I am currently breastfeeding. Had body aches; chills; fever of 102.6; headache; nausea; cough; shortness of breath - I went to ER and that is where I received COVID positive test and positive tests for COVID Pneumonia and Microplasm Pneumonia as well. Stayed overnight in ER observation - 2 am to 8 am . Went home next morning and was quarantined approximately 8 days. Body aches and a cough had started two days prior to injection. IV antibiotics at the hospital and oral antibiotics at home. Received nebulizer breathing treatments. Pain meds and anti-inflammatory medication.
36 2021-01-12 numbness, tingling Numbness in neck and face on left side lasting for 3-4 days; now intermittent tingling in face and n... Read more
Numbness in neck and face on left side lasting for 3-4 days; now intermittent tingling in face and neck on left side; no facial droop
36 2021-01-12 tingling, numbness Numbness,tingling in both upper and lower extremity, especially left foot and hand which began sever... Read more
Numbness,tingling in both upper and lower extremity, especially left foot and hand which began several hours after vaccination. Day 6 post vaccine, numbness and tingling began in right hand. Associated symptoms include heaviness, mild weakness of extremities described above.
36 2021-01-12 unresponsive to stimuli, feeling hot Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic.... Read more
Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic. Prior to the syncope, she reported hyperventilating. She remained unresponsive for about 10 minutes and was brought to the ED. There she became responsive, and reported chest pain and had sinus tachycardia episodes. She also had lower extremity weakness. This has improved per the latest neurology notes. She also had a negative EEG. Unsure if this is an allergic reaction or if the syncope was due to hyperventilation. Patient is currently on day 3 of hospitalization.
36 2021-01-12 movement disorder, lethargy Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt ... Read more
Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt like she had resistance against her movements, and was "going through jello". She went home, took Benadryl 25 mg, now with rash/hives along various areas, behind her ears. Has an epipen at home but has never had to use. Denies any throat swelling or scratching, no shortness of breath.
36 2021-01-12 numbness, pain in extremity Severe pain and numbness in Left arm , forearm and hand. It lasted for one day.
36 2021-01-12 lethargy Swollen lymph nodes at various times over 2 weeks. Consistent, intermittent headaches. Lethargy.; Co... Read more
Swollen lymph nodes at various times over 2 weeks. Consistent, intermittent headaches. Lethargy.; Consistent, intermittent headaches; Swollen lymph nodes at various times over 2 weeks. Consistent, intermittent headaches. Lethargy.; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 Lot number=EL1284, via an unspecified route of administration on 22Dec2020 11:15 at single dose in the left arm for COVID-19 immunization. Medical history included Allergies to Penicillin. Concomitant medication included melatonin, diphenhydramine hydrochloride (BENADRYL) and celecoxib (CELEXA). On 21Dec2020 19:00 (pending clarification), the patient experienced swollen lymph nodes at various times over 2 weeks, consistent, intermittent headaches and lethargy. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 04Jan2021. The outcome of the events was unknown.
36 2021-01-12 dizziness, tingling, weakness Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy... Read more
Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy", weakness, seeing stars. Appeared pale and clammy. Eased to floor to lie flat. B/P=92/62. B?P after 5 min of being supine 102/64. Able to sit up after 10 minutes. Continued to rest for 30 minutes with slow consistent improvement in weakness and dizziness. Left clinic within one hour with improvement.
36 2021-01-12 tingling, numbness light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my uppe... Read more
light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my upper back/worsening muscle pain everywhere; a headache; a slightly sore throat/worsening sore throat; a fever; chills; nausea; severe fatigue; tingling; numbness in all extremities at random locations; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), intramuscularly on 05Jan2021 at 18:30 on Left arm at single dose for COVID-19 immunization in hospital. None other vaccine received on same date. The patient medical history included Hypothyroid Generally healthy; Hx of depression and ADHD (Attention deficit hyperactivity disorder); and prior to vaccination, patient was diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); ibuprofen; cetirizine hydrochloride (ZYRTEC). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly on 15Dec2020 at 18:30 on Left arm at single dose for COVID-19 immunization; and had known allergies with Sulfa and ciprofloxacin hydrochloride monohydrate (CIPRO) drugs, tramadol and oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET). The patient experienced on 06Jan2021 at approximately 9am hour, she noticed joint pain in her fingers while typing, muscle soreness in her upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. Then at 3pm, about 21 hours since vaccination-fever had broken once but returned quickly, and severe headache with light sensitivity. The joint pain and numbness had faded but she was left with severe muscle soreness, like she was in a car accident. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event Muscle soreness was not recovered, outcome of the other events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
36 2021-01-12 pain once by injection in the left shoulder/Shoulder pain; Whole body was hurting; Nausea; This is a spon... Read more
once by injection in the left shoulder/Shoulder pain; Whole body was hurting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Batch/lot number: EL3246, expiry: unknown), via an unspecified route of administration on 30Dec2020 at single dose (once by injection in the left shoulder) for COVID-19 immunization (Healthcare worker). Medical history was reported as none. There were no concomitant medications. On 01Jan2021, it was reported that the patient experienced shoulder pain, whole body was hurting, and nausea. Patient asked, after getting the vaccine, if one was able to get COVID, she clarified that she meant after the first dose of the vaccine. She got the typical symptoms and side effects after she got the first dose, like shoulder pain. She is curious if you can still get COVID after the first dose. She is sure you are better off after the second one, but was curious about after the first one. The patient was taking COVID Vaccine because she is a Healthcare worker. Patient is a medical assistant. It was also reported that her shoulder pain was more prominent than her body. She works in the field and people are getting COVID after the first dose of the vaccine. She is concerned on if she could still get it or not. She gets the second dose on 20Jan2021. The outcome of the event once by injection in the left shoulder/Shoulder pain was recovered on 04Jan2021, whole body was hurting was recovered on 02Jan2021, and nausea was recovered on 01Jan2021.
36 2021-01-13 pain in extremity, dizziness, tingling, numbness, pain After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection ... Read more
After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection site pain for two weeks. After second Vaccine given at 9:55am. tingling of feet for about 20 mins, 30 mins after the vaccine. Two hours later fatigue, body aches, headache and nausea began. At 0030 1/12/2021 I woke up with severe chills and left chest pain, temp was 101.6 and heart rate was 160. I began to see black and chest pain was severe feeling like i was having a heart atack and was going to pass out so i called 911. I then began to get short of breath and got numbess on my legs, left arm and left side of neck. Chest pressure/pain radiated to left arm and neck. I was taken by the ambulance to hospital. Arrived around 0130. My heart rate sustained at 140s in the ER so I was admitted at 0530 am. My D Dimer was a bit elevated as well as my lactic so I was given a bolus of fluids plus maintenance. I had a CXR done, CTA chest(negative for PE), UA, Labs, entire cardiac workup including an ECHO during my admission. I also began to have loose stools and wrist joint pain. MY heart rate sustained at 125-147 for about 30 hours. Fevers on and off. After everthing was negative we determined this was secondary to the covid 19 vaccine. I was discharged 1/13/2021 at around 1:30 pm. My heart rate is still not at baseline which is 87-90. I'm 100-130 and still get very fatigued with a simple slow walking. Still having tachycardia, fevers, body aches, joint wrist pain, chest discomfort and headaches. My potassium was 3.0 at discharge so will be needing labs in a week. Also bruised a little different than I usually do with lab draws so keeping an eye on them and will be checking my platelets again in a week. Ive been taking tylenol for my fever and pain and ativan for any anxiety when my heart rate goes up. (treatment during hospital stay was normal saline bolus, nomal saline maintenance fluids at 150 cc/hr, tylenol, ativan, ice packs, rest)
36 2021-01-13 unresponsive to stimuli Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseou... Read more
Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseous, roused me to say so, and then immediately became unresponsive and pulseless. She was admitted to hospital for cardiac work up, and all diagnostic tests have found her heart to be normal in structure and function. Cardiology believes she experienced a vasovagal syncope with asystole. She remains hospitalized at this time for initiation of sotalol therapy; she was diagnosed with frequent PVCs approximately 1 year ago.
36 2021-01-13 pain Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, start... Read more
Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, started the night of the vaccine and continuing today, two days post.
36 2021-01-13 tingling, dizziness Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult wit... Read more
Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult with an Allergist. Dizziness, Lightheaded, Tongue and Facial Tingling
36 2021-01-13 pain in extremity Headache, arm pain, fever
36 2021-01-13 dizziness Headache,dizziness, sob, chest pain, nausea, vomiting, fever, muscle and joint pain.
36 2021-01-13 pain Headache; body aches; didn't feel good; joint pain and muscle aches and fatigue; Lasted about 24 hou... Read more
Headache; body aches; didn't feel good; joint pain and muscle aches and fatigue; Lasted about 24 hours exactly. Then felt fine after that. Pregnant: June 21, 2021; noneventful
36 2021-01-13 feeling cold, pain in extremity, pain In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever... Read more
In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscularly on 06Jan2021 14:45 at single dose in Left arm for COVID-19 immunisation. No Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Irritable bowel syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included fluticasone propionate, ethinylestradiol, norethisterone (WERA). The patient experienced In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4 on 07Jan202105:30 AM. No treatment received for the adverse events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.
36 2021-01-13 dizziness Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous repo... Read more
Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 36-year-old-female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO140), via an unspecified route of administration in right arm, on 06Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to gluten and penicillin (PCN). There were no concomitant medications. The patient previously took cefaclor (CECLOR) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in the patient's workplace clinic. The first dose was given at 08:30 on 06Jan2021. A few minutes after, the patient became dizzy and lightheaded for what seemed like a minute or two and then she was fine for the remainder of her 15-minute observation. Around 17:00 that day, the patient became itchy on her right arm and upper right torso area, no rash or swelling was noted. Itching subsided around 20:00 - almost 12 hours post-vaccine. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 06Jan2021 ("Itchy on her right arm and upper right torso area" at 20:00).
36 2021-01-13 lightheadedness, pain, pain in extremity My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at... Read more
My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at 0800 on 1/12/21. First symptom was on 1/12 at 2000 when I had a headache and malaise so I went to bed early. Woke up at 0200 on 1/13 with nausea, body aches and chills. My temp felt fever-ish (100.4 via temporal scan). So I took Tylenol and Pepto to go back to sleep. Same symptoms carried throughout the morning of 1/13. By noon 1/13 = my L arm where the injection had occurred was swollen, painful and hard to move. That evening I had a presyncopal event where I felt flushed and nearly passed out. My L arm continued to hurt but the swelling moved down into my lymph nodes where lymphadenopathy continues to be a problem until now.
36 2021-01-13 vertigo, dizziness Nausea and dizziness. Gave me meclizine for vertigo
36 2021-01-13 pain Nose bleed x 2 on 1/13/21. Fever 100.5, HA, Body aches, stomach pain, tachycardia. Treatment Ibuprof... Read more
Nose bleed x 2 on 1/13/21. Fever 100.5, HA, Body aches, stomach pain, tachycardia. Treatment Ibuprofen and Tylenol outcome: Mild improvement.
36 2021-01-13 pain Patient reports mild body aches, cold sweats and fatigue. Also a mild sore throat and slight headach... Read more
Patient reports mild body aches, cold sweats and fatigue. Also a mild sore throat and slight headache
36 2021-01-13 feeling hot, pain in extremity Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1... Read more
Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1/10/2021 had small patch of hives on ankle, took zyrtec resolved 1/11/2021 felt ok no symptoms 1/11 to 1/12 night "woke up and had massive allergic reaction everywhere - patches of redness on leg, arms, belly, back, face-sparing" -- took zyrtec and the reaction improved somewhat. Was in clinic so went up stairs and spoke to our dermatologist who thought this was likely reaction to vaccine. Prednisone RX given but has not taken. Takes 1-2 zyrtec daily. Spoke to me on the phone 1/12 at night, increased zyrtec to 4 pills daily, added pepcid and decided to speak today. Did not take atarax or benadryl bc she was on call. Improves with triamcinolone Presents today with worsening rash, she will upload pics in Epic. Areas of urticarial patches from yesterday now have left non blanching purple rash/bruising. More urticarial plaques today. No angioedema. Feels hot has not take temperature. No joint pain or swelling. No oral or vaginal mucosal involvement. No issues with respiration generally but maybe a little tight. >75% BSA involved Allergy history - chronic rhinitis, no known triggers or patterns No history of asthma, eczema, food allergy or drug allergies
36 2021-01-13 pain Pfizer-BioNTech COVID-19 Vaccine Patient described immediate jaw clenching/tightness within first ... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient described immediate jaw clenching/tightness within first 10 minutes after vaccine, that only now subsided about 72-80 hrs later. Along with this severe body aches, soreness, chills.
36 2021-01-13 pain, weakness Rigors, fever , body pain, chills, diaphoresis, fatigue, weakness .lymphadenopathy left axilla
36 2021-01-13 weakness Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and r... Read more
Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and rigors, muscle pain, extreme weakness and fatigue. Affected my ability to function. Took Tylenol. Took almost 48 hours to recover.
36 2021-01-13 pain Symptoms - ? EE reports around 5:00 PM began with arm soreness near injection site, at 8:00 PM +lowe... Read more
Symptoms - ? EE reports around 5:00 PM began with arm soreness near injection site, at 8:00 PM +lower back pain, 10:00 PM + body aches and chills, midnight: temp 99.6. Last day of work and shift - ? unsure, EE reported did not work yesterday or today; next scheduled shift tmw Home remedies? - Tylenol 500 mg at midnight and 0600 on 1/14/21 Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE encouraged to rotate Tylenol 500 mg and motrin 400 mg q3h for body aches, EE verbalized back understanding. EE educated to continue to manage per TCH Illness in the Workplace Policy. EE verbalized back understanding and denied further questions at this time.
36 2021-01-13 pain in extremity, tremor, feeling cold, pain Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including b... Read more
Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including breast, under arms, legs, feet stomach. Horrible headache that did improve with tylenol and ibuprofen taken at the same time. Body shakes and can't control body temperature. Felt freezing cold but skin was very hot to the touch (according to my husband). Then, I started sweating and felt really hot and couldn't cool down. Felt nauseous but no vomiting. Could not sleep but felt very tired. Today is now 48 hours after vaccine and body aches are gone but I am still extremely fatigued.
36 2021-01-13 feeling cold, feeling hot, dizziness The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restro... Read more
The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restroom. While washing my hands I became extremely dizzy, hot and nauseous. While bending over to open the toilet (so that I could vomit) I ended up passing out. I woke up on the floor of my bathroom (with my head against the wall), somewhat disoriented, shortly thereafter (exact timeframe that I was "down" is unknown). I tried to get up and get back to bed but became extremely dizzy and hot again - this time bringing myself back down to the floor. I laid there for an unknown amount of time before feeling like I could try to move again. Once I felt a little better I crawled back to bed and laid down. I believe I was out of bed for a total of 15-20 minutes. I had no further dizzy/hot/nauseous episodes after that, however for the remainder of that day I felt exhausted, had a mild headache and felt like I couldn't get warm. I did not take my temperature. At about the 48-hr mark post-vaccination I was feeling back to normal other than a slight headache.
36 2021-01-13 pain, numbness Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sa... Read more
Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sat morning 1/9/21 woke up with left arm weakness and numbness which went up to her face. Had an MRI completed which showed a new small right paritial ischemic stroke.
36 2021-01-14 dizziness, pain, feeling cold After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish and... Read more
After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish and having body aches and headache.i just rest in bed and took advil that night and tylenol on the 2nd day.until now on and off feeling fatigue,body aches, headache and fever.
36 2021-01-14 pain in extremity, pain Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21. ... Read more
Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21. Fatigue and body aches lasted the entire next day and resolved by the morning 1/15/21. No fever
36 2021-01-14 pain Chills; headache; diarrhea; vomiting; body ache; received second dose BNT162B2(lot number EI1283) , ... Read more
Chills; headache; diarrhea; vomiting; body ache; received second dose BNT162B2(lot number EI1283) , intramuscular at Arm Left on 08Jan2021; received second dose BNT162B2(lot number EI1283) , intramuscular at Arm Left on 08Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 36-Year-old female patient received second dose BNT162B2(lot number EI1283) , intramuscular at Arm Left on 08Jan2021 19:00 at the 36 years old at single dose for COVID-19 immunization. The medical history included Asthma and Dm(Diabetes mellitus). The patient was not Allergies to medications, food, or other products. There were concomitant medications but unspecified. The patient previously took first dose BNT162B2 (lot numberEJ1685) on 21Dec20200 6:30 PM at 36 years old Intramuscular at Left arm for COVID-19 immunization. The patient experienced Chills, headache, diarrhea, vomiting, body ache on 09Jan2021 02:30 AM. It was unknown if there was treatment received for the adverse events Chills, headache, diarrhea, vomiting, body ache. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The information on the batch number has been requested.
36 2021-01-14 pain Fatigue, malaise, and mild body aches from about 12 hours to 36 hours post vaccine. Then, starting a... Read more
Fatigue, malaise, and mild body aches from about 12 hours to 36 hours post vaccine. Then, starting about 4 days post vaccination, noted 2 enlarged (1-2cm) right axillary lymph nodes and 1 tender 2-3cm enlarged supraclavixular lymph node. These lymph nodes are on the same side and area that the vaccine was received. It is 7 days post vaccine and the nodes persist but are less tender.
36 2021-01-14 dizziness First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to se... Read more
First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to severe site pain. approximately 12 hours post vaccine, patient experienced nausea, dizziness, fatigue, headache. 3 hours following, patient continued to have the same symptoms along with mild shortness of breath and tachycardia with mild to moderate exertion, such as walking up a flight of stairs.
36 2021-01-14 pain in extremity Left arm was sore on 01/13 Diarrhea started on 01/14, along with nausea
36 2021-01-14 weakness, numbness My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I ten... Read more
My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I tend to have a rapid hart beat but this was pumping pretty good). I also had some GI distress (watery diarrhea) and that lasted for a while. Later I got really weak and shaky, fatigued, that night I woke up with night sweats, and chills, woke up completely drenched, I had to change the sheets and pajamas. 5 days after the vaccine I was really exhausted, the fatigue was awful. There was also an itching sensation but no hives.
36 2021-01-14 dizziness Not dizzy, but disconnected. On a boat feeling. Could not walk straight, weaving. No treatment. Pass... Read more
Not dizzy, but disconnected. On a boat feeling. Could not walk straight, weaving. No treatment. Passed after a few minutes on its own.
36 2021-01-14 tingling On 1/13/21 I noticed some tingling in my feet and hands. This has continued and worsened - I have co... Read more
On 1/13/21 I noticed some tingling in my feet and hands. This has continued and worsened - I have constant "pins and needles" sensations in both feet and it is extending up to my knees. It's also in both hands and extending up my arms. Last night it was up to elbows, now it's going above my elbows. It doesn't go away. I was unable to sleep well because of the sensations. I'm also starting to feel tingling in my back and shoulders. I called my doctor and he said to fill out this form and report the ER if my symptoms don't improve over the weekend.
36 2021-01-14 dizziness, pain, weakness Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout m... Read more
Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout my extremities; dull body aches; nausea induced vomiting; dizziness; weakness. I was unable to sleep throughout most of the night. I used tylenol and ibuprofen for my symptoms which didnt seem to alleviate any of the symptoms during the night. Woke up on 01/15/2021 with a rash on my face.
36 2021-01-15 pain in extremity Chills, headache, sore arm, tired
36 2021-01-15 pain Severe chills Fever 102.8 Body aches Fatigue Headache Metallic taste for days
36 2021-01-15 pain Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bo... Read more
Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bone on same side as injection site.
36 2021-01-16 pain, pain in extremity Arm soreness, body aches, headache, fever of 99.6, fatigue
36 2021-01-16 pain in extremity At about 12 hours after the second dose I had chills, headache, fever of 101, fatigue and nausea. It... Read more
At about 12 hours after the second dose I had chills, headache, fever of 101, fatigue and nausea. It lasted for about 24 hours. My arm was also sore for about 72 hours after the shot. I did not have any reaction from the first dose except for a sore arm.
36 2021-01-16 tingling, dizziness Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine ... Read more
Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine administered. She also experienced intermittent tingling in hands and feet. Patient was evaluated by EMS in the vaccine clinic. The chest symptoms were episodic, occurring every 5 minutes and lasting 1-2 minutes with each episode. Intermittent dizziness also occurred during the chest-discomfort symptoms. Vital signs were stable and oxygen saturation was 100% on room air. Patient denied SOB, stridor and no labored breathing. Patient was transported to the hospital emergency department for further evaluation/observation. After 2 hours of observation, patient's symptoms resolved spontaneously. She discharged from the emergency department to home with family.
36 2021-01-17 feeling hot 1 hour post injection patient returned with redness and borderline hives in her left arm, chest, nec... Read more
1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.
36 2021-01-17 pain Body pain, headache, difficulty swallowing
36 2021-01-17 facial paralysis Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself). A 36-... Read more
Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received bnt162b2 (COVID-19 Vaccine by Pfizer, lot EK9231, expiry date was not reported), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for Covid-19 immunisation (to prevent the COVID). Medical history was none. There were no concomitant medications. The patient experienced facial paralysis on the left side of her face upon waking up on 09Jan2021. The outcome of event was not recovered.
36 2021-01-17 facial paralysis, tingling Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/d... Read more
Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/droop 4 days post vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination/Tingling to lower extremities; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EK9231), via an unspecified route of administration in the left arm on 04Jan2021 13:00 at single dose, for Covid-19 immunisation. The vaccine was given in a Nursing Home/Senior Living Facility. Medical history was none. No known drug allergies. No other vaccine in four weeks. No Covid-19 prior vaccination. Concomitant medication included naproxen sodium (ALEVE). The patient experienced tingling in injected arm and facial tingling in cheeks/lips same day of vaccination (04Jan2021). Tingling to lower extremities the day after vaccination (still continuing). Slight left sided facial weakness/droop 4 days post vaccination (04Jan2021). Tingling to left arm continuing on and off. No treatment reported. On 04Jan2021, she was negative to PCR covid test post vaccination. She went to the Emergency room/department or urgent care. The outcome of events was not recovered.
36 2021-01-17 dizziness Tachycardia, lighthead, dizzy
36 2021-01-17 tenderness Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and n... Read more
Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and neck. Profound fatigue. methylprednisoLONE (Medrol, Pak,) 4 mg tablet and azithromycin (Zithromax Z-Pak) 250 MG tablet mono test negative After 5 days on medications nodes size reduced, tenderness, stiffness, fatigue remain, but overall improved.
36 2021-01-17 tenderness few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the... Read more
few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the time of vaccination; large mass appeared in right axilla; mass was painful to touch; large mass appeared in right axilla; mass was painful to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of bnt162b2 (COVID 19, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 23Dec2020 07:15 at a single dose for COVID-19 immunization in a hospital. The patient had no relevant medical history and no known allergies. The patient was pregnant at the time of vaccination, last menstrual date was on 05Oct2020, delivery date will be on 12Jun2021, gestation period: 11. Concomitant medication includes daily multivitamin. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 30Dec2020 04:00 am, 7 days after vaccine (as reported), a large mass appeared in right axilla. The mass was painful to touch. Overnight mass more than doubled in size on 31Dec2020 the mass took up her entire arm pit, went to immediate care and was given antibiotics. The mass decreased in size but has not gone away. She followed up with primary care. She had bloodwork and ultrasound of axilla and right breast. Blood work was normal. Ultrasound showed a few enlarged and abnormal lymph nodes believed to be reactive in nature. Largest lymph node as of 08Dec2020 2.5 x 0.9 x 2.2 cm. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
36 2021-01-19 pain in extremity, migraine, pain 1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAI... Read more
1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAIN, LOW GRADE FEVER (99.8) AND SEVERE HEADACHE. SWOLLEN FACE AND ARM PAIN. 1/8 NIGHT: HIGH GRADE FEVER (101.4). 1/10: HIGH GRADE FEVER (101.3 REACHING HIGHEST OF 102.9). SEVERE BODY ACHES, CLUSTER HEADACHE/MIGRAINE, JOINT PAIN. CILLS, COLD SEATS, LOSS OF APPETITIE, NAUSEA. SWOLLEN FACE AND ARM PAIN. 1/11 MORNING: LOW GRADE FEVER, MODERATE BODY ACHES, CHILLS AND COLD SWEATS, NAUSEA (STRONGER), LOSS OF APPETITE AND STOMACH ACHE, DIARRHEA, AND ARM PAIN. 1/11 AFTERNOON AND NIGHT: MODERATE STOMACH ACHE, NAUSEA. 1/12: STILL MILD NAUSEA AND LOSS OF APPETITE, ARM PAIN. TOOK IBUPROFEN, TYLENOL.
36 2021-01-19 pain 11 hours after the second Pfizer Covid dose I started experiencing fatigue, mental cloudiness, and n... Read more
11 hours after the second Pfizer Covid dose I started experiencing fatigue, mental cloudiness, and neck pain. Around 18 hours post vaccine I had sever body aches, headaches, and chills. I have had to take extra strength Tylenol and Motrin to combat the symptoms.
36 2021-01-19 pain in extremity, pain Arm pain, body muscle aches, fever, fatigue. 48 hours
36 2021-01-19 weakness, pain Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, ... Read more
Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, weakness, body aches, headache, decreased appetite. Symptoms significantly improved after 3-4 days
36 2021-01-19 migraine, pain The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my ... Read more
The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my body all through the night. This morning on 1/20/21 I had a horrible migraine that lasted till 3:30pm. All the symptoms went away by 4:30pm
36 2021-01-19 weakness fever, headache, weakness/ fatigue
36 2021-01-19 involuntary muscle movements sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a cont... Read more
sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a contactable nurse (patient). This 36-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 07Jan2021 10:00 for covid-19 immunisation. Medical history included hypotension, rheumatoid arthritis, asthma. Concomitant medication included clonazepam, methylprednisolone. On 07Jan2021 21:00, the patient experienced sinus arrhythmia, night sweats, heart rate low, dyskinesia, all with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events included Inderal 10mg. The events were assessed as congenital anomaly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-01-20 vertigo Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-con... Read more
Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-contactable other Health Care Professional (HCP). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown), intramuscularly, on 04Jan2021 at 10:00 AM (at the age of 36 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. No allergy information was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jn2021, the patient experienced fatigue, chills, headache, nausea, vertigo and sore throat. The events resulted in a physician office visit. Treatment information was not provided. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date after the vaccination the result of which was negative. The clinical outcomes of fatigue, chills, headache, nausea vertigo and sore were reported as recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
36 2021-01-20 numbness, tingling treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tin... Read more
treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tingly; My arms were very numb and tingly; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown lot number), via an unspecified route of administration in left arm on 30Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included prior history of panic attacks, HPV, and known allergies to pets and pollen. Concomitant medications included naproxen sodium (ALEVE), cyclobenzaprine, and aspirin. The patient was vaccinated in a hospital on 30Dec2020 at 09:30. The early morning of 06Jan2021 at 03:15 AM, the patient woke up with very alarming symptoms. She woke up very suddenly and was having difficulty getting thoughts together, her arms were very numb and tingly. She has had panic attacks before, and this did not feel like anything she had experienced. The events resulted in emergency room (ER)/department or urgent care visit. In ER, the patient treated as panic attack, no testing done. The patient was treated for the events. The patient did not have COVID prior to vaccination and the patient was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.
36 2021-01-21 pain Feeling febrile, headache, severe body aches, fatigue, joint pain and weakness in arm shot was given... Read more
Feeling febrile, headache, severe body aches, fatigue, joint pain and weakness in arm shot was given (lasted the longest)
36 2021-01-21 numbness, tingling I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injec... Read more
I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injection arm). Later in the evening I had the same feeling in my left leg and in my cheeks, lips, tongue and teeth. I felt like I had been numbed at the dentist, but was coming out of the numbness. It was like when the numbness is mostly gone and you're left with that tingling sensation, and your face feels puffy. It was basically that feeling in my face, left leg, and left arm. Those sensations are mostly gone today (the second day following), but not quite.
36 2021-01-21 tingling Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left ... Read more
Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left arm swelling, tingling and discomfort. Pt alert, oriented and denies any respiratory symptoms. Gave Benadryl 25 mg po at 1758 and pt states "50 mg makes me tired and I live out of town". Gave second dose of Benadryl 25 mg po at 1800 when pt began feeling "like my tongue is swelling". Contacted Med ER team to assist with monitoring. Removed pt rings and bracelets on left wrist/hand as pt states "feel like my whole arm is swelling". BP: 122/78 Rt. Arm with apical HR: 60/min and regular. Injection site Left deltoid is not red but swelling noted and spreading. Area is normal temp to touch. Tried ice bag to injection site left deltoid which made it feel worse per pt. The ice made the arm area red. 1818 BP: 136/90. Med team arrived and decision made to transport pt to ED for observation. Pt assisted to wheelchair for transport. Report given to RN from ED. Pt remained alert and oriented throughout. Pt contacted her family herself to notify. Pt received Solumedrol and Famotidine in the ED. Pt was observed and discharged within an hour. Pt follow up with Employee Health provider 1/22/21. Pt continues to experience intermittent rash/hives on chest/neck relieved by Benadryl, Headache, and entire left side feeling tingling and "weird".
36 2021-01-21 pain Severe headache and neck pain for two weeks. Tired and body ache Shingles on third week
36 2021-01-21 numbness The patient developed numbness to left cheek and tightness in her chest 30 minutes after she receive... Read more
The patient developed numbness to left cheek and tightness in her chest 30 minutes after she received the vaccine. The patient was seen in the ED and given Benadryl and Pepcid. She never developed a rash or difficulty breathing. He O2 sat was 98% and ED provider told patient she more than likely had a panic attack.
36 2021-01-21 numbness The person developed some numbness to the left cheek of the face. We watched the individual and held... Read more
The person developed some numbness to the left cheek of the face. We watched the individual and held her for additional 30 minutes and then she states she had tightness in her chest. She was seen in the ED. No other symptoms developed at this time. She was given pepcid and benadryl in the ED. She was told she had a mild anxiety attack but she states the medications did help.
36 2021-01-24 dizziness Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contact... Read more
Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contactable physician, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced arm pain at injection site, runny nose, and lightheaded. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of arm pain at injection site, runny nose, and lightheaded were unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
36 2021-01-24 pain in extremity, migraine, dizziness Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitiv... Read more
Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitive to light, dizzy, extremely tired. Day 3: headache, nausea, vomiting, diarrhea, dizzy, resting heat rate above 100, exhaustion. Day 4: shaky, dizzy, nauseous, resting heat rate not below 100 for several hours, heart palpitations, heart beating very hard at times, exhaustion.
36 2021-01-24 lethargy, pain Fever, body aches, diarrhea, lethargic, cold sweats.
36 2021-01-24 tingling, numbness NUMBNESS AND TINGLING ON LEFT LEG. IT STARTED ON LEFT HIP AND WENT DOWN TO LEFT FOOT.
36 2021-01-24 restlessness her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is no... Read more
her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is now hives on chest, back, arms, and at injection site.; her chest had a red spot; vivid dreams; restlessness; This is a spontaneous report from a contactable Nurse. A 36-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot# EK9231) vaccine , intramuscular in the left arm on 11Jan2021 08:00 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to azithromycin, morphine and sulfa. Concomitant medication included levothyroxine (LEVOTHYROXINE), liothyronine (LIOTHYRONINE), abaloparatide (TYMLOS). The patient received the first dose of bnt162b2 vaccine on 21Dec2020 . The patient experienced her chest had a red spot on 11Jan2021 10:00 with outcome of unknown , vivid dreams on 11Jan2021 with outcome of unknown , restlessness on 11Jan2021 with outcome of unknown , her spot on chest is now hives on chest, back, arms, and at injection site on 12Jan2021 14:00 with outcome of unknown. The patient received cetirizine (ZYRTEC) and acetaminophen (TYLENOL) as treatment of rash. Further information has been requested.
36 2021-01-25 pain, pain in extremity warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on s... Read more
warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection; Severe burning with injection followed by mild soreness at arm; Severe burning with injection followed by mild soreness at arm; redness; moderate soreness; Itchy; This is a spontaneous report from a contactable Other HCP (patient). This 36-year-old female (not pregnant) patient received 2nd dose of BNT162B2 (Covid vaccine, lot number=EK4176 on 09Jan2021 09:30 AM on Left arm for covid-19 immunization. Medical history was migraines. Concomitant drug was sumatriptan succinate (IMITREX) for migraines, ethinylestradiol norgestimate (SPRINTEC). Historical Vaccine was 1st dose of BNT162B2 on 19Dec2020 08:15 AM (lot number=EK 5730, vaccine location=Left arm) and experienced moderate soreness at injection site only x2 days. It was reported that patient experienced Severe burning with injection followed by mild soreness at arm. Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection. 10Jan2021 - moderate soreness. Area remains bright red, raised, warm to touch increased in size to 1"x1" 24 hours after vaccine. 11Jan2021 - 48 hours post vaccine area further enlarged to 2"x2". Moderate soreness. Itchy. Warm to touch. Palpable area extending to edge of redness. 12Jan2021 - 72 hours. No soreness except when touching injection site. Redness less in color and size. No longer itchy. Palpable lump smaller. Quarter size. Treatment was Tylenol. Outcome of the event palpable lump, Redness was recovering, for itchy was recovered, for other events was Not recovered. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are needed. No further information is expected.
36 2021-01-26 pain, facial paralysis 1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild... Read more
1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild pain and muscle stiffness at injection sight. Chills and body aches. 1/21/2021woke up with itching on left side of face a scalp. 1/22/2021 itching subsided 1/23/2021- left side face drooping started.
36 2021-01-26 vertigo, dizziness 6 Days after the vaccine I experience dizziness with passing out feelings, vertigo which lasted over... Read more
6 Days after the vaccine I experience dizziness with passing out feelings, vertigo which lasted over seven days, chest pain?s, heart palpitations
36 2021-01-26 pain Chills on the evening of injection. The next day 1/26/21 - 100.2 fever, headache, body aches- 600mg... Read more
Chills on the evening of injection. The next day 1/26/21 - 100.2 fever, headache, body aches- 600mg of ibuprofen taken once around 8 AM. Fever and body aches improved post ibuprofen, headache persisted. Evening of 1/26/21 fever seemed to return at 99.1 but resolved the morning of 1/27/21. Injection site reaction of warm, red, slightly raised bump noted on the AM of 1/27/21- no action taken at this time
36 2021-01-26 numbness, tingling Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, to... Read more
Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; This is a spontaneous report from a contactable other hcp (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on the left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included endometriosis, gastrooesophageal reflux disease (GERD) and liver lesion; all from an unknown date. Concomitant medications included fish oil (FISH OIL), omeprazole (PROTONIX [OMEPRAZOLE]) and sertraline hydrochloride (ZOLOFT); all were taken from an unspecified date for an unspecified indication. The patient previously took amantadine and experienced drug allergy. On 12Jan2021 03:00, the patient experienced facial swelling, and numbness and tingling of mouth, tongue and face. Therapeutic measures were taken as a result of facial swelling, numbness and tingling of mouth, tongue and face. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered.
36 2021-01-26 dizziness Itching of chest and arms, Redness at injection site, Lightheaded 15min after vaccine
36 2021-01-26 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Arm soreness the evening of injection and the following day. H... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Arm soreness the evening of injection and the following day. Headache the night of injection
36 2021-01-26 pain in extremity, dizziness Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started... Read more
Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started having neck pain on my left side until now and irradiate toarse my shoulder and arm p to my hand on left side also random days present dizziness when I lie down blurry vision. on January 19 had neck pain shoulder pain and headaches on left side too went to Dr. and his medical diagnosis was muscle spasm might be induce due to stress pre-scribe Diazepam 5 mg . start taking it on Wednesday January 20-2021 but Saturday January 23 my upper lip started getting swollen , IL STOP THE MEDICATION ON MONDAY JANUARY 27 LIPS got better but still filling burning sensation inside mucosa on left side of the lip. still mild swollen started taking Zyrtec my concern is second doses of Pfizer vaccine is this Friday 29 should I get it or wait ?? what I Have could be effects from first Dose??.
36 2021-01-26 dizziness right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymp... Read more
right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymphnodes; headache; fever; fatigue; Vomit; Dizzy; rash not sure first time but within first 12 hours over chest and trunk; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 36-year-old female patient received second dose (lot number: Ek9231) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 36-years, on 08Jan2021 19:00 (07:00 PM) at single dose in right arm; first dose (lot number: Eh9899) on 18Dec2020 07:00 PM at single dose; both via unspecified route of administration for COVID-19 immunisation in hospital. Medical history included thyroid issues; allergies to latex and adhesives. No COVID prior vaccination. No other vaccine in four weeks. Patient is not pregnant. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA). The patient previously took thimerosal and experienced allergy to it. On 08Jan2021, the patient experienced vomit and dizzy within 1 hour of vaccine. Rash not sure first time but within first 12 hours over chest and trunk. On 09Jan2021 (next day) headache, dizzy, fever, fatigue. On 11Jan2021 (after 2 days), right armpit and axilla swelling, pain in lymphnodes. It was unknown if treatment was received or not. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. No COVID-19 tested post vaccination.
36 2021-01-28 tingling Tingling and pins and needles throughout the body (head, arms, neck, back) occurred immediately post... Read more
Tingling and pins and needles throughout the body (head, arms, neck, back) occurred immediately post vaccination, patient was given 25mg of benadryl after 30 minute wait period and still reported tingling after 15 minutes. 30 minutes after benadryl no more tingling was reported.
36 2021-01-28 feeling cold, dizziness feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedn... Read more
feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedness; weakness of lower extremities; Nauseated; felt really cold; probably had a fever; really thirsty; very hot; she wasn't feeling well; This is spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular (deltoid left) on 14Jan2021 18:25 at 0.3 mL, single for Covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took Bactrim and experienced allergy. The patient reported she did develop some side effects, but the hospital she received the vaccine at didn't know if it was an allergic reaction or what. She reported that a minute or two minutes after receiving the COVID-19 vaccine (14Jan2021), her heart rate became very fast, it went into like the 150's. She started feeling jittery, lightheaded, and she had some weakness of her lower extremities. She also felt nauseated. She didn't have any shortness of breath; she thinks she was okay there. She clarified that she had her mask on and they told her to remove her mask and to breathe, breathe, breathe. She had a pulse oximeter on, and her levels were always at 98, 96. She was told to sit still, and she was given water. Her heart rate went down to 76. She was fine and then after 5 minutes, she had the same reaction again. Her heart rate this time was in the 120's. She was lightheaded, cold, jittery. She did the same thing again and waited another 5- 10 minute. She felt better but was still nauseated, lightheaded, and really, really cold. She was kept there for 45 minutes. After that, she still did not feel 100%. Currently, she still does not feel 100% well. She was okay, she thinks she was okay. She explains they wanted to send her to the ER (emergency room) but she declined. Her heart rate had improved, she wasn't feeling like she was going to pass out. She wasn't experiencing shortness of breath, she wasn't throwing up, she didn't have a rash, her throat wasn't closing up, so she went back to work. She further stated that she came back home. Her heart rate was a little faster, but it wasn't as high as it had been. She still felt a little bit of weakness. At night (14Jan2021), she probably had a fever, she doesn't know. She was really thirsty and very hot. Because she was not feeling well, she didn't get up and drink anything. This morning (15Jan2021), she feels a little better. If she is doing her normal activities, she does get tired. She feels like she is running and is like "okay I feel tired". She has a little bit of weakness in her lower extremities. She was given information for reporting side effects, but because she wasn't feeling well, she didn't do any of it. She checked her heart rate today (15Jan2021) and it's at 76. She added that when she moves a lot, she feels tired and she doesn't know why. She's normally a very active person. She is no longer jittery, but still feels lightheaded. She has a little bit of nausea. She felt hungry so she made a shake and it's not like she is going to throw up, but she is still feeling yucky. She still has a little weakness of her lower extremities. They feel light, she doesn't know how to explain it. She is just a little bit concerned because this is a new vaccine. The outcome of event heart rate increased was recovering; outcome of event feeling jittery was recovered on an unspecified date; while the outcome of other events was unknown. The patient confirmed he doesn't believe it to be life threatening. She doesn't know if this is a severe allergic reaction. She was reading on the side effects the COVID-19 vaccine can cause. Per reporter all events were related to suspect product.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162b2 to the event heart rate increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-28 weakness night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactab... Read more
night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactable physician. This 36- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via intramuscular route of administration, on 28Dec2020 at 01:00 pm (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the left arm. The medical history was not reported. Concomitant medications included Levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 11:00PM, she experienced a "Fever hours", night sweats, myalgias, weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events "Fever hours", night sweats, myalgias, weakness and fatigue were recovered without treatment. On 31Dec2020, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
36 2021-01-28 speech disorder, weakness, dizziness, pain tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard fo... Read more
tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention. Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago). Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine. The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-31 pain Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCH... Read more
Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCHY- uncomfortable ER VISIT - Hospitalized Medicine- Prednisone, Zyrtec, Pepcid
36 2021-02-01 pain in extremity, dizziness Facial flushing that was more prominent on the left side of my face and left ear flushing and burnin... Read more
Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.
36 2021-02-01 dizziness Started with some nausea around noon on 1/18 that resolved, then experienced nausea without emesis a... Read more
Started with some nausea around noon on 1/18 that resolved, then experienced nausea without emesis and palpitations while driving to work at 1800. She describes it as feeling like her heart was racing, but also feeling like she was having large pauses in her heart rate in between the palpitation sensations. She drank a bottle of water and the feeling went away temporarily but it returned. I am an employee, on arriving to work I noted increased shortness of breath which is unusual for me because I am an avid runner and very active. I noted the palpitations from around 1800-2000, including becoming dizzy and lightheaded during my shift which could endanger patient care, so I presented to the ED and was placed in the CCA. I had received both covid vaccines, second one on 1/11/21 and had about 20H malaise/fatigue and some expiratory wheezing which was abnormal for her but all has since resolved. I had intermittent heart palpitations and chest until 1/26
36 2021-02-01 tingling Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive house... Read more
Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive household members. Developed symptoms (headache) 1/25/21. Developed sensation change (pins and needles) in left arm 1/31/21. Was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found.
36 2021-02-02 dizziness, weakness On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, ... Read more
On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, chest tightness, diarrhea, feeling of something stuck in her throat globus sensation, weakness. She went to the ER on 1/18/21 they felt she had gastritis and gave her fluids, Zofran and COVID test which was negative, then they sent her home. It continued where she could not eat, could not sleep, felt like she was going to die. She ended up going back to the ER again on 1/23/21. They did a CT scan, EKG, gave her IV fluids, flu and an antimotility agent for the nausea. They did lab work to rule out other tests. Did stool culture, blood work. She got admitted over night, then she had endoscopy on 1/24/21 to rule out any issues with her throat since she felt like it was closing on her. They said her esophagus looked fine, took biopsies. All the tests that were done were negative, and sent her home on 1/24/21. Then on Monday, 1/25/21 went to see a ENT specialist who also did a scope to loop down her throat to se if anything was blocked and felt that it was inflammation due to vomiting. Advised to take Proton pump inhibitor to help with the acid reflux from the vomiting. The GI doctor called on 1/26/21 showed some H-pylori, but did not know why she had that. Was started on antibiotics for that. She saw her PCP on 1/28/21, who did work up for celiac disease, thyroid scan/studies and all tests were negative as well. Right now she is home and the plan is to wait it out and to see if she gets better over time. She still having today 2/3/21 diarrhea, no appetite, cannot sleep, occasional chills, no fever, headache, chest tightness, nausea but is taking Zofran, still having the globus sensation in her throat. States her "body is not well", weakness as well.
36 2021-02-04 dizziness, feeling hot hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; diffi... Read more
hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
36 2021-02-07 tingling, migraine, dizziness, tenderness, pain in extremity, pain She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to tou... Read more
She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to touch. She was sensitive all over.; Chest burning and hurting; Joint pain; extremely dizzy; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; arm was sore/soreness where they gave the vaccine on her arm all the sudden came back very suddenly; The lady that gave it was not gentle. She screamed.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1284) via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient had headaches in the past. The patient's concomitant medications were none. The patient got vaccine on the 03Jan2021 and her arm was sore, but she felt like this was normal, just like it would feel after a flu shot. Throughout the next week, she was extremely stressed for work. By Friday, which would have been 6 days later. She was feeling really off wellness wise. She was very fatigued, and extremely dizzy on 07Jan2021. On Saturday night 09Jan2021, she felt very bad. She had a sore throat, she was coughing, her chest was burning and hurting. She had severe chills and aches. She thought maybe she needed more sleep because she works out 6 days a week. She felt like she was in over drive like she was killing herself. Sunday morning 10Jan2021, she felt bad. She has so much adrenaline. She was always on the go. She decided to take a nap before the gym Sunday, and she woke up with a huge migraine. She had headaches in the past, but never a migraine. Her head was hurting so bad it woke her up. It hurt all over. She also felt like she had taken a hammer to her joints and bones. Her joints and bones were hurting. She has never felt that before. Her muscles were so achy. Her skin even hurt to touch. She was sensitive all over. She had severe chills. The soreness where they gave the vaccine on her arm all the sudden came back very suddenly. It came back the same day as the other symptoms started. They mostly started on the 09Jan2021, and then on the 10Jan2021 they were worse while migraine and bone hurting were occurred on 10Jan2021. She assumed there were subtle symptoms leading up to the 09Jan2021, but she just didn't realize it. That was a Saturday and Sunday. The lady that gave it was not gentle. She screamed. The side effects lasted at least 5 days after the 10Jan2021. On the 10Jan2021, she did not feel well so she got tested for COVID because her boss told her to. They tested her Flu, COVID, and strep. She only tested positive for COVID on 10Jan2021. She felt like she wouldn't be able to drive. She couldn't walk for 4 days. She felt most of the symptoms had gone away around 5 days after the 10th except fatigue, feeling dizzy, and headaches here and there. She also had a little coughing here and there. That started 09Jan2021 and was ongoing but improved. She got the vaccine because the doctor at her practice really encouraged her to get it done. She also thought if she ever wanted to travel that she might need it. She thought in the long run she might benefit from having the vaccine. She felt peer pressured honestly to get it because she was sketched out to get it at all. She wants to know the rate of people testing positive for COVID after getting the vaccine. The outcome of the events sore arm, chest burning, joint and bone pain, skin even hurt to touch and sensitive was recovered on 15Jan2021, the outcome of the events screamed and couldn't walk was unknown and the outcome of the other events was recovering.
36 2021-02-10 migraine, dizziness Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salt... Read more
Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salty/rotten; Diarrhea; Vomiting; intestinal discomfort; Cough with some shortness of breath (relieved with asthma inhaler); Cough with some shortness of breath (relieved with asthma inhaler); This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Solution for injection; lot number: EL3249, expiration date: unknown) via unspecified route of administration in the arm left on 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included asthma, multifocal myoclonus, IBS/lynch syndrome, hypothyroidism, Allergy: Dairy (milk allergy), allergies, alcohol allergy, Allergy: beef (meat allergy), and allergy: adhesives (dermatitis contact). Patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: urgent care center (also reported as Doctor's office). The patient experienced mental foggyness/forgetful, chills, migraine, dizziness, fatigue, loss of appetite, food tasted salty/rotten, diarrhea, vomiting, intestinal discomfort, and cough with some shortness of breath (relieved with asthma inhaler); all on 23Jan2021 at 06:00. The events resulted to: Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken in response to all events (unspecified). Patient also had teleconference with doctor. Outcome of all events was recovering.
36 2021-02-16 tingling sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Teste... Read more
sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Tested positive for COVID 23Jan2021/headache; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 05Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. Medical history included known allergies: coconut. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was tested positive for COVID (test name was reported as COVID-19/SARS COV2, PCR (COVOO)) on 23Jan2021. Patient was asymptomatic at the time and was tested due to positive household members. Patient developed symptom (headache) on 25Jan2021. Patient developed sensation change (pins and needles) in left arm on 31Jan2021. Patient was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found. No treatment was received for the events. Outcome of the events was reported as resolving. This case was reported as serious with seriousness criteria: caused/prolonged hospitalization.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
36 2021-02-17 vertigo Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous r... Read more
Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous report from a contactable other health professional reported for herself. A 36-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration in right arm on 15Jan2021 12:00 at single dose for covid-19 immunisation. There were no relevant medical history or concomitant medications. The patient was not pregnant at the time of vaccination.The patient had no allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 21Jan2021, exactly "4 1/2 days" after vaccine the patient experienced fainting like episodes, blurred vision, severe vertigo, chest pain, fatigue. The patient has been out of work since the 20th and she still had blurred vision. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received. The patient was not recovered from the events. She has been to the ER, cardiologist for an echography, ultrasonography of thyroids, Magnetic resonance imaging (MRI) of her head, went to ENT dr and neurologist in 2021. All blood work in 2021 came back normal as well. The reporter considered the event as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. She had negative Nasal Swab Covid test post vaccination on 22Jan2021.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of fainting like episodes cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-02-21 lethargy 15 hours after injection I experienced severe joint pain all over my body. This continued until 32 h... Read more
15 hours after injection I experienced severe joint pain all over my body. This continued until 32 hours post vaccine. Motrin and Tylenol helped but didn?t completely take all pain away. Injection arm was slightly sore. I was lethargic until 36 hours post vaccine. All symptoms subsided the next morning.
36 2021-02-21 pain Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with larg... Read more
Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with large red, hard and very sensitive to touch circle around it about 1.5-2 inches wide that is hot to touch. Has been there now for almost 4 days with no signs of easing up yet.
36 2021-02-21 weakness Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird through... Read more
Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird throughout the morning: fatigue - didn't want to move at all but not moving wasn't comfortable; fever, chills, joint and muscle aches - mostly in my back (I couldn't get comfortable) - felt like I had been hit by semi truck. Very weak - if that was a 10th of what COVID felt like, I didn't want it! Those symptoms lasted about three to five days. By the5th day - I was mostly back to myself. I took Motrin - which helped slightly for headache.
36 2021-02-21 tingling after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touch... Read more
after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touching skin), heat causes itching and tingling and well as redness and swelling with hotter temperatures at longer durations. This has been occurring since after receiving the first vaccine, with increased severity after the second. The symptoms last from 20-2 hours after exposure and then resolve.
36 2021-02-21 tremor, lightheadedness woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; ha... Read more
woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021. The outcome of events was recovering. The reporter assessed the events as not serious. Information on the lot/batch number has been requested.
36 2021-02-22 tingling About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack. My hea... Read more
About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack. My heart was racing and a tingling adrenaline feeling started in my head and spread down through my body. My throat felt strange, but I could still breathe. It started to subside after a couple of minutes but didn?t resolve completely for another hour or so. I also had a headache almost immediately. In the days following the vaccine I had such sore muscles it was hard to get out of chair or go upstairs. That lasted 3 days. About one week after the shot I started noticing my brain felt glitchy. At night I have not slept well since about one week after the vaccination and I frequently awaken feeling confused, stressed, and disoriented. This is not normal for me. Additionally, about 3 weeks after the vaccine I had another mild panic attack. I have not been troubled by panic attacks before getting the vaccine. As of today I am starting to feel less glitchy in my thinking. I am still not sleeping soundly and waking often, sometimes accompanied with confusion.
36 2021-02-22 dizziness, feeling hot Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of b... Read more
Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of body, sweating on neck, and light headed, clamminess to hands. Vitals monitored. no medications given.
36 2021-02-22 pain Chills, body aches, lymph node swelling, headache, severe fatigue, purple bruise, swallowing issue
36 2021-02-22 pain in extremity, pain Headache, Tired, Fatigue, Leg and arm shooting pain
36 2021-02-22 pain in extremity Herpes simplex 1 outbreak of oral lesions 48 Hours after receiving vaccine Arm soreness and nausea ... Read more
Herpes simplex 1 outbreak of oral lesions 48 Hours after receiving vaccine Arm soreness and nausea 24 hours after receiving vaccine
36 2021-02-22 swollen extremities Pain to left axilla with swelling, redness to inject site one week later, general fatigue x 1 week.
36 2021-02-22 pain Staff reports feeling nauseaus, vomitted, shivers and general body aches, had a hypertensive episode... Read more
Staff reports feeling nauseaus, vomitted, shivers and general body aches, had a hypertensive episode BP of 150/100 at around 7:30am, was offered to be sent to hospital ER, was discharged from the hospital the same day with no new recommendations. Staff sent to hospital ER for evaluation, no new recommendation made, no further symptom reported
36 2021-02-23 tingling, numbness 1/6 vaccination 1/7 typical immune system response; recovered in 12 hours. 1/8 Woke up and my left ... Read more
1/6 vaccination 1/7 typical immune system response; recovered in 12 hours. 1/8 Woke up and my left hand was weak, numb and tingling in glove distribution. The right hand started to have problems as evening came. The right hand resolved within 12 hours. The left hand symptoms persisted for 6 weeks. *unable to work for 6 weeks. **Still having symptoms in middle finger, pointer finger; left hand. 1/8 I went to urgent care; referred to ED. They did put me in the clinical observation unit, discharged the next day. I went to PCM 2 days later. Dr. didn't know what to think of symptoms. Had me try some steroids. Hospital referred me to neurology; He had me do another MRI (1st in the ER). EMG. He didn't find anything unusual except some nerve damage; carpal tunnel *Symptoms are still persisting. It has gotten better but the 2 fingers are still an issue.
36 2021-02-23 feeling hot 12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat ... Read more
12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat on hand and elbow on the left side; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 26Jan2021 at 07:30 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included caffeine/paracetamol (EXCEDRIN), paracetamol (TYLENOL) and ergocalciferol (VIT D). Past drug history included known allergies: cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Jan2021 at 19:30, 12 hours after vaccination, the patient experienced redness and heat on hand and elbow on the left side. Treatment included applied Burts Bees lotion on hand and elbow for the event redness and heat. The outcome of the event redness and heat was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
36 2021-02-23 dizziness Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as ... Read more
Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; I was nauseous and couldn't walk; I was nauseous and couldn't walk; Felt like immediate drop in blood pressure; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN5318, via an unspecified route of administration at left arm on 09Feb2021 10:00 at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On 09Feb2021, exactly two hours after injection, the patient felt lightheaded and dizzy while driving, then tunnel vision as if she was going to pass out. The had muscle weakness in my arms and legs. The patient managed to pull over safely. She was nauseous and couldn't walk. This lasted about 15 minutes and then she was better. The patient felt like immediate drop in blood pressure. No treatment was received. The outcome of the events was recovered on an unspecified date.
36 2021-02-23 pain, weakness, dizziness Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched ... Read more
Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
36 2021-02-23 pain I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hour... Read more
I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hours after adminstration; dull headache and intense body aches approx 8 hours after administration; dull headache and intense body aches approx 8 hours after administration; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on the left arm at the age of 36 years, on 26Jan2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included anaphylactic reaction, drug hypersensitivity to penicillin, food allergy to pistachios. The patient's concomitant medications were not reported. The patient had the first dose on an unspecified date in Jan2021. On 26Jan2021, the patient experienced light nausea approx 2 hours after administration. Then developed a dull headache and intense body aches approx 8 hours after administration. The patient was currently 20 hours post administration of 2nd dose (27Jan2021) and feels lousy. There was no treatment received for the adverse events. The outcome of the event feel lousy was unknown while other events were recovered on an unspecified date in Jan2021.
36 2021-02-23 pain, migraine woke during the night with chills, body aches, and migraines, hurts to walk
36 2021-02-25 migraine 1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hour... Read more
1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explore; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; This is a spontaneous report from a contactable self-reporting other health professional. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686), intramuscularly on an unspecified date in Jan2021 at 13:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included anaphylactic reactions to penicillin and pistachios. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered to the patient in a hospital. The patient reported that twenty-four hours after administration she developed a searing migraine that lasted for approximately fifteen hours. She stated that "no medications could touch the pain" and it felt like her brain and eyeballs were going to explode. The patient specified that she did not receive any treatment for the events. The clinical outcomes of migraine, sensation of pressure and eye discomfort were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
36 2021-02-25 pain in extremity arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female pati... Read more
arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first vaccine back and everything went great. She had that usual arm pain on Jan2021. There was no treatment for the event. Outcome of the event was unknown.
36 2021-02-28 dizziness, balance disorder Headache , Dizziness, unsteadiness, diploplia, blurry vision started 1 week after second dose
36 2021-03-14 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (reported for herself). A 36-year... Read more
Sore arm; This is a spontaneous report from a contactable consumer (reported for herself). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3247), on right arm via an unspecified route of administration on 27Jan2021 10:15 at single dose for covid-19 immunisation. The patient's Medical history and concomitant drug was not reported. The patient experienced sore arm on 28Jan2021 06:00. Prior to vaccination, patient was not diagnosed with COVID-19, Prior to vaccination, patient was not diagnosed with COVID-19, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination. Outcome of the event was not recovered
36 2021-03-18 numbness severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; T... Read more
severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the perniosis of bilateral hands and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-03-21 facial paralysis left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting; This... Read more
left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: ENG6202; expiration date: unknown), at vaccination age 36-year-old via an unspecified route of administration in the left arm on 02Mar2021 17:00 as a single dose for covid-19 immunisation. Medical history included pecans allergies. The patient was not diagnosed with Covid prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), desogestrel, ethinylestradiol (ISIBLOOM), citalopram and vitamins nos (MULTIVITAMINS reported as WOMANS MULTI-VITAMIN). The patient did not receive other vaccine in four weeks The patient received the latest vaccine dose in a hospital. The patient had left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting on 03Mar2021 06:00 AM. The patient did not received treatment for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was not recovered.
37 2020-12-31 speech disorder, dizziness TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10... Read more
TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10min.
37 2021-01-01 weakness Overwhelming fatigue/weakness
37 2021-01-01 pain, dizziness Patient developed site injection (left arm), then headache, body aches, joint pain, and dizziness
37 2021-01-01 vertigo, dizziness soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented sta... Read more
soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented standing, nausea, extreme fatigue). Pt has never experienced vertigo before. On 1/2/21 some mild dizziness remains though the pt can resume normal activity in the home.
37 2021-01-02 pain Body aches, chills, exhaustion, fever, injection site itching, swelling and redness.
37 2021-01-03 tingling 5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat.... Read more
5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat. 10-15 minutes later, it happened again. Denies shortness of breath, some itchiness on tongue. Tongue was not swollen. Advised to take oral Benadryl. Total monitoring time = 40 minutes and was discharged/released home.
37 2021-01-03 numbness After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, a... Read more
After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, and tongue. This lasted ten to fifteen minutes followed by mild itching of the ears, face, and neck. Upon returning home, contacted my primary physician to report the adverse reactions and self administered Benadryl which eliminated the s/s thus far.
37 2021-01-03 dizziness Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), r... Read more
Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), rigors. The urgent response team started iv fluid 1L, gave solumedrol (IV) and Benadryl (IM). Paramedics transferred me to ER (which was downstairs in hospital). After 1 hour the hives faded and gone by 2h. They kept me for observation for 5h. I did not have any difficulty breathing, did not receive Epi.
37 2021-01-03 tingling, numbness Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18... Read more
Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18. Was fine for first 15 minutes. Within 5-10 minutes of leaving, ee had facial numbness to right side of face and under bottom lip. Sx lasted about 3 hours and resolved 100%. No recurrence.
37 2021-01-03 dizziness Dizziness post vaccine, came back to clinic and ate snack bc she had not eaten that morning. BP 130/... Read more
Dizziness post vaccine, came back to clinic and ate snack bc she had not eaten that morning. BP 130/80, felt better with food. 2 similar episodes the following day, no further epidose after 48h.
37 2021-01-04 numbness Developed left facial numbness but no weakness present; This is a spontaneous report from a contacta... Read more
Developed left facial numbness but no weakness present; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, intramuscularly at the left arm on 17Dec2020 at 16:15 (04:15 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient's medical history included hypothyroidism, hypertension, and premenstrual dysphoric disorder (PMDD). The patient had no allergies to medications, food, or other products. Concomitant medication included atenolol, fluoxetine hydrochloride (PROZAC), and levothyroxine; all received within 2 weeks of vaccination. The patient reported that on 17Dec2020 at 18:00 (06:00 PM), she developed left facial numbness but no weakness present. Symptoms come and go. Sometimes last for hours, never had this before. The patient did not receive treatment for the event. The clinical outcome of the event was not recovered. The event was reported as non-serious. Information on the lot/batch number has been requested.
37 2021-01-04 tingling Facial swelling/tingling, lip swelling and tingling and tongue swelling
37 2021-01-04 migraine Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; s... Read more
Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; severe diarrhea; vomiting; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient, non-pregnant, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in hospital, via an unspecified route of administration on 23Dec2020 at 10:30, at 37-years of age, at single dose in right arm for COVID-19 immunization. Medical history included anxiety, depression and migraines, all from an unknown dates. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), ibuprofen and levocabastine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache/migraine 6-24 hours after vaccine (onset reported also as 25Dec2020 at 12:00 - to be clarified) and, on 25Dec2020 at 12:00, also reported as 24-72 hours after vaccine, she experienced intermittent severe stomach cramping, nausea, severe diarrhea and vomiting. The patient didn't receive any treatment for the events. The outcome of the events was unknown at the time of the report. Information on the lot/batch number has been requested.
37 2021-01-04 pain in extremity It still hurts to abduct my left arm; This is a spontaneous report from a contactable Physician (pat... Read more
It still hurts to abduct my left arm; This is a spontaneous report from a contactable Physician (patient). A 37-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 37-year-old. Lot number was EJ1685. Medical history was unknown and concomitant medications were unknown. Patient was not pregnant at the time of vaccination. It was reported that since 19dec2020 it did still hurt to abduct left arm.. The patient was not treated for the event. The patient did not recover from the event.
37 2021-01-04 dizziness Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25m... Read more
Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25mg of diphenhydramine orally and observed. Patient quickly began feeling better, hives disappeared. The patient left with 2 other coworkers.
37 2021-01-04 dizziness, tingling Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes... Read more
Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes after that felt lightheaded and tachycardic. Rapid response called while patient laid flat, transported to the ED. In the ED, vital signs were stable and was able to ambulate without problems.
37 2021-01-04 pain in extremity severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-conta... Read more
severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), intramuscular in the right arm on 23Dec2020 10:15 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies. The patient has no COVID prior vaccination, and COVID was not tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and vitamin c (ascorbic acid). The patient has no other vaccine in the past four weeks. On 23Dec2020 01:00 PM, the patient experienced severe sore arm in limb it was given (by nighttime she was almost unable to use her right arm, improved by next morning), nausea, and fatigue. The outcome of the events was recovered in Dec2020. No treatment was received for the adverse events. The report was considered non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
37 2021-01-05 difficulty speaking, dizziness 8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registe... Read more
8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registering in ER tachycardia. Throat mouth dry and tight change to hoarse voice lightheaded. EpiPen administered. Ekg done. Other meds provided: 500 ml saline bolus. Famotidine, prednisone, benadryl Angioedemia and readmittance to ER approximately 18hrs later: prednisone,epipen, benadryl iv and po, famotidine, saline bolus
37 2021-01-05 facial paralysis, numbness After receiving the vaccine, the patient ended up with a mild case of Bell's palsy. Symptoms includ... Read more
After receiving the vaccine, the patient ended up with a mild case of Bell's palsy. Symptoms include: mild numbness up to the maxillary bone, and a weak smile (doesn't go up on the right). Her Smile is asymmetrical.
37 2021-01-05 pain in extremity Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneo... Read more
Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#EK9231) for the first dose via intramuscular in the left arm on 22Dec2020 12:00 for COVID-19 immunization. Medical history included post viral syndrome (COVID) or long COVID from Mar2020. The patient had undetectable antibodies in Apr2020. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC +), colecalciferol (VITAMIN D), cobamamide (VITAMIN B12), bifidobacterium lactis (PROBIOTIC). The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies (NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19 since the vaccination. The patient had arm soreness 3 days, 1 headache, fatigue starting from night of injection increasing to requiring 1 hour nap on day 6 and 7, myalgias and arthralgias day 6 and 7; events onset date reported as 22Dec2020. Blood drawn 1 week after injection and the patient had undetectable antibodies in Dec2020, no movement in her CD4 or CD8 in T lymphocyte panel. The events resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.
37 2021-01-05 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patien... Read more
Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 29Dec2020 17:50 (5:50 pm) at a single dose as Covid vaccine. Medical history included hypertension and depression. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); olmesartan medoxomil (BENICAR); and unspecified medications for depression and blood pressure medication (hypertension). It was reported that the reporter's nurse got her vaccine last night, about 6'o clock at night, and woke up with Bell's Palsy on Dec2020. She woke up in midnight to go to the bathroom and when she looked in the mirror, she noticed that there was discrepancy. The physician examined her this morning, so it was in several hours getting the vaccine that she noticed it. She got the vaccination last night at 5:50 pm. When she went to bed it wasn't a problem. She woke up at midnight and noticed it. The patient was started on Medrol dose pack but she hasn't taken it yet because she's at work so she would start it today (unknown if the treatment was already received); it's steroid, Methylprednisolone, at 24 mg on day one and then decreases 4 mg a day over the next five days until it's done. The doctor inquired what should the patient do about her second dose and also asked if she should not get her second dose. The outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-01-05 pain Fever 100, chills, body aches, joint pain
37 2021-01-05 feeling hot Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours.
37 2021-01-05 dizziness, feeling of body temperature change, tingling MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HE... Read more
MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING. PATIENT DID NOT FAINT. PATIENT DID VOMIT ONCE. PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2 1303 VITALS: BP: 116/99 P: 96 SA02: 100% PATIENT STATES THEY ARE FEELING BETTER. GIVEN JUICE AND BANANA. 1312 VITALS: BP: 128/87 P: 74 SA02: 100% PATIENTS COLOR HAS RETURNED TO NORMAL. STATES THEY ARE FEELING MUCH BETTER. ABLE TO STAND AND WALK WITHOUT DIZZINESS. PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE. PATIENT LEFT WITH HER WORKMATE.
37 2021-01-05 migraine Migraine headache, vomiting 2pm day of Overnight fever 101.5
37 2021-01-05 tingling Parasthesias began in my lower extremities intermittently about 36 hours following administration. T... Read more
Parasthesias began in my lower extremities intermittently about 36 hours following administration. These spread to my upper extremities and became consistent. Occasionally will appear in lips and trunk. These are associated with sensation of numbness and some discomfort in my extremities. I'm also experiencing significant brain fog, difficulty concentrating, and fatigue. Headaches are occurring about every other day. Symptoms are present currently and have remained relatively consistent in severity. Was evaluated by urgent care on December 28 and encouraged to observe. Was evaluated in the ER by neurology on January 4. There leading hypothesis is vaccine related immune response. Neurologic exam was largely normal, being evaluated by a specialist in the coming days.
37 2021-01-05 movement disorder Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, ... Read more
Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; cold; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; feeling unwell that night, unable to sleep, tossing and turning all night; feeling unwell that night, unable to sleep, tossing and turning all night; This is a spontaneous report from a contactable nurse (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included food allergy (known allergies: raw bananas, avocados, melons, kiwi, tomatoes, oranges, grapes-make her mouth and lips itch). Concomitant medications were not reported. The patient previously received ibuprofen 400mg, a couple doses week prior. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Patient is not pregnant at the time of vaccination. On 29Dec2020, at 21:00, patient experienced worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dreams. When she was able to sleep, she was still feeling unwell the next morning like she was recovering from a cold. The patient did not receive treatment for the events. Outcome of the events was recovering. Since the vaccination, patient has not been tested for COVID-19.
37 2021-01-06 pain 103 fever severe body aches chills and fatigue
37 2021-01-06 pain 5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-... Read more
5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-7/10 and has decreased mobility of shoulder. sporadic burning sensation in arm between elbow and wrist.
37 2021-01-06 nerve pain, numbness, pain Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left sid... Read more
Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left side. Both times I was vaccinated in my left arm. The first shot I experienced numbness to my left face, neck, ear and eventually my left arm and leg. I had no trouble with movement, the sensation felt dull. There was no associated pain. Numbness resolved completely after 2 days. The second shot, I again about 20 minutes following experienced numbness to my left face and ear. This time it resolved after a few hours. Also, two days following the first shot, I experienced severe nerve pain in my low neck/ upper back radiating down my right arm. As I do not remember injuring it, I am unsure if this is related to the vaccine or not. It has lessened in severity over time but is still present 3 weeks later.
37 2021-01-06 pain Fever, Severe headache and body aches, Tachycardia 120-150, Shortness of breath, Hypertension 160/11... Read more
Fever, Severe headache and body aches, Tachycardia 120-150, Shortness of breath, Hypertension 160/110
37 2021-01-06 dizziness, pain HEADACHE, BODY ACHES, LEFT ARM SORE AT INJECTION SITE, DIZZINESS
37 2021-01-06 migraine Migraine-like headache, low grade temp, extreme exhaustion, congestion
37 2021-01-06 tingling Patient began to have tingling under her right eye and face, then she began to have a rapid pulse (1... Read more
Patient began to have tingling under her right eye and face, then she began to have a rapid pulse (156), she felt chest heaviness, contact clinic. Clinic suggested taking patient to the hospital to be evaluated. Patient decline the ride to clinic but stated she would have her spouse take her to the hospital.
37 2021-01-06 pain Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her ... Read more
Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her shoulder was achy and the pain rated 4/10 was radiating to her back. I checked the injection site and arm and it was not red, raised, or warm. Pt did not have any other symptoms, just the achy shoulder. Pt also reported a brief burning sensation in her shoulder that subsided within 1 minute. She later felt that same sensation in her forearm and it also subsided. It was recommended that she go to the ED for monitoring since the pain was radiating further from her shoulder. ED RN took her in at 0905 and I left.
37 2021-01-06 tremor, dizziness Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely d... Read more
Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely dizzy and getting "tunnel vision." Patient sat down on the floor of her own accord without injury or difficulty. Had patient elevate her legs above heart level. Checked patients vitals, her blood pressure was low, but O2, respiration and pulse were within normal range. Patient was shaking and reported her tongue felt "tingly" and "heavy on my chest." Patient reported she had a smoothie prior to coming in for her appointment. She was given sprite. Patient felt better, but approximately 7 minutes later reported her stomach felt queezy. Blood pressure had improved and other vitals were still stable. Patient still reported her tongue felt "tingly," but no swelling, trouble breathing, or throat tightness. Patient was picked up by her father 45 minutes later and was able to ambulate to the car (with supervision) of her own accord without assistance.
37 2021-01-06 numbness, tingling Several minutes after the vaccination was administered she began experiencing numbness and tingling ... Read more
Several minutes after the vaccination was administered she began experiencing numbness and tingling down her right arm to her fingers.
37 2021-01-07 dizziness 16 Dec 2020 @1303: received dose at 0820, reports onset of chills and N/V sometime after 0900, >10 e... Read more
16 Dec 2020 @1303: received dose at 0820, reports onset of chills and N/V sometime after 0900, >10 episodes, intermittent lightheadedness. Also mid-sternal, non-radiating CP described as "burning and heaviness" that began approx. 6 min before ED arrival. Given 1L NS IV, GI cocktail PO, and Zofran, Benadryl, Solumedrol, and Pepcid IVP. Reported complete resolution of symptoms at 16 Dec 2020 @1529.
37 2021-01-07 dizziness 16 hours post shot, developed severe myalgias all over body, fever of 101, pain in my spine, back ne... Read more
16 hours post shot, developed severe myalgias all over body, fever of 101, pain in my spine, back neck, most of my muscles. Nausea. Lightheaded, dizzy. Left neck, chest and armpit lymphadenopathy.
37 2021-01-07 weakness, pain in extremity At 8:10 am Thursday started with a fever and swelling of my lymph nodes under my arm on the injectio... Read more
At 8:10 am Thursday started with a fever and swelling of my lymph nodes under my arm on the injection side, left, and just not felling well. By 2:30 pm on Thursday had high fever, muscle, bone and joint pain, weakness, chills and sweats. Pain in my swollen lymph nodes under arm. Fever broke Friday at 9 am still experiencing pain in lymph nodes, some sweating, generalized tiredness and over all just not feeling well.
37 2021-01-07 pain Body aches and fever 100.4
37 2021-01-07 dizziness, weakness, pain Chills, Dizziness, Night Sweats, Headache, Nausea, Body Aches, Weakness, Fatigue and Joint Pain
37 2021-01-07 pain Comparable to COVID symptoms I had in October. Fever, headache, aches, painful"bee sting" type at i... Read more
Comparable to COVID symptoms I had in October. Fever, headache, aches, painful"bee sting" type at injection site.
37 2021-01-07 dizziness Ears ringing, fatigue, diarrhea, headache and dizziness
37 2021-01-07 pain in extremity Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal conge... Read more
Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal congestion, myalgias, then right forearm rash, itchy abdomen Benadryl/atarax without effect. COVID-19 test 12/28/2020 NEG result. Feeling slightly better today. COVID-19 test #2 scheduled for 01/04/2020.
37 2021-01-07 pain Fever, chills, body aches, severe headache, nausea, vomiting
37 2021-01-07 dizziness Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treat... Read more
Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treatment: Observation, fluids, food Summary: Sxs resolved after one hour of close monitoring Reported history of allergies: No, but pt had hx of new onset arrhythmia a few months prior
37 2021-01-07 dizziness Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait ... Read more
Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait time because of prior history of anaphylaxis (non-vaccine). Within a few minutes she developed light-headedness and dizziness, these symptoms continued to worsen so she notified our nurse who was observing post-vaccine patients. She was promptly wheeled to our anaphylaxis room at 8:50 and placed in semi-Trendelenburg position. In addition to light-headedness and dizziness. she reported mild neck tightness and throat fullness. She had facial flushing and conjunctival injection with some tearing. She was monitored for Vital Signs and Oxygen Saturation. Within 20 minutes her symptoms progressed to chest heaviness, increased effort to take a breath and shortness of breath. She was mildly tachycardic with HR 96, though did not become hypotensive, B/P was 140/92. She had no gastrointestinal symptoms. She was anxious and "did not feel right", but did not report "impending doom". At 9:05 Epinephrine 1:1000, 0.3mL was administered IM, upper-outer thigh. Symptoms began improving within 8 to 10 minutes and were mostly gone by 9:20. At 9:17 she was given Diphenhydramine Solution 25mg, Famotidine 20mg, Prednisone 20mg. Her vital signs and Oxygen Saturation remained stable. (see flow sheet) Patient was monitored by an RN for 2 hours in our anaphylaxis room, on monitors, full crash cart present.
37 2021-01-07 pain Slight fever, 99.4, (ordinarily I run lower than normal), severe body aches, and chills.
37 2021-01-07 pain in extremity, pain Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that ... Read more
Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that lasted 12 hours
37 2021-01-07 pain in extremity, pain Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches... Read more
Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches, sweats, extreme fatigue, and headache by 7:00 am the next day.
37 2021-01-07 tingling Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more... Read more
Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches. Persistent sxs.
37 2021-01-07 tingling, dizziness, numbness Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and le... Read more
Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet, hands and feet became ice cold, headache, joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend). confusion, inability to focus and complete thoughts and sentences. 911 called @12:04 PM by friend. At time of paramedics evaluation BP 175\100, O2 SAT 100%, loss of consciousness 2x(reported by friend) before being transported to University of Alabama at Birmingham (UAB) ER. No treatment except basic vitals taken, Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not. Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
37 2021-01-07 dizziness feeling of dizziness and becoming lightheaded at times; This is a spontaneous report from a contacta... Read more
feeling of dizziness and becoming lightheaded at times; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 28Dec2020 06:00 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient had been having a constant feeling of dizziness and becoming lightheaded at times, it varied in severity but it was constant on 31Dec2020 08:00 with outcome of not recovered. Patient didn't receive treatment for events. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
37 2021-01-07 tremor, pain in extremity headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wig... Read more
headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wigged her out/shortness of breath; sore in both arms/Both of her arms were sore; Her sats dropped to 92% on a pulse ox/oxygen saturation dropped; shortness of breath wigged her out; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. The medical history included she had COVID back on 11Oct2020. The concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 21Dec2020 and 2nd dose is due on Friday. She reported being sore in both arms and short of breath, stats 92% on pulse ox. The day after the vaccine, on 22Dec2020 she had the same symptoms as when she had COVID. Both of her arms were sore. She was short of breath. Her sats (saturation) dropped to 92% on a pulse ox (oximetry). The shortness of breath wigged her out. She stated she experienced shortness of breath and her oxygen saturation dropped for 48 hours. She was healthy before this with no preexisting conditions. She didn't know if she should get the second vaccine. She read most people are getting a bigger response from the second vaccine. She stated she also had a headache on an unspecified date. She had a headache for 24 hours and she experienced both arms being shaky on an unspecified date. The patient stated her symptoms were similar to when she had COVID and that she did not wait 90 days before getting the first dose of the COVID vaccine since she had COVID. She was scheduled to receive her second dose of COVID vaccine on 08Jan2021. She wanted to know if she was going to end up with a bigger reaction. The patient would like to know if she should receive the second dose since she had a reaction to the first dose. The events were reported as non-serious. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
37 2021-01-07 pain nausea, headache, body aches, general malaise
37 2021-01-07 pain in extremity sore arm/ arm started to get sore; This is a spontaneous report from a contactable consumer (reporte... Read more
sore arm/ arm started to get sore; This is a spontaneous report from a contactable consumer (reported for herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly on 16Dec2020 at single dose at right upper arm for COVID-19 immunization. Medical history included Asthma: She explained she had seasonal asthma as a kid and as she got older, it got worse, she couldn't remember when. The patient's concomitant medications were not reported. The patient received the first COVID vaccine on 16Dec2020. She clarified further with the first vaccine, she was fine. She had a sore arm and that's it in Dec2020. With the first COVID vaccine, she had a sore arm but has recovered completely from it. She got the first vaccine and it didn't hurt or anything. Her arm started to get sore in the early hours of the morning like 1am. She thought it took her 2 days to recover completely and then she was fine. Investigation Assessment was no. Vaccination Facility Type was Hospital, not Administered at Military Facility. The outcome of the event was recovered on an unspecified date in Dec2020.
37 2021-01-08 pain Aches, Chills, Nausea, vomiting, fatiuge - 48 hours. chest tightness- 6 hours
37 2021-01-08 tingling After a few minutes of administration, I felt tingling down my right arm, my right side of the face,... Read more
After a few minutes of administration, I felt tingling down my right arm, my right side of the face, and my tongue. My eye started to hurt with pressure. The tingling in my arm and hand went away after 30 minutes or so but there was still some tingling of my face, toungue and the pressure of the eye still remained. That night I took a Zyrtec and felt better for a few days. on 1/8 I started to feel tinging in my tongue and pressure in my right eye again. I took Zyrtec that night and it went away. Currently this morning I feel okay and hope it wont come back.
37 2021-01-08 pain in extremity Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my ... Read more
Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my hip and knee joints, hot sweats alternating with chills, I did not take my temperature. I woke up the next morning with a headache and skin sensitivity. I took ibuprofen alternating with Tylenol and started to feel better. I felt back to normal about 36 hours after receiving the vaccine.
37 2021-01-08 pain Day 1: shoulder pain, headache, fatigue, and temp of 99 Day 2: severe nausea, fatigue, headache, and... Read more
Day 1: shoulder pain, headache, fatigue, and temp of 99 Day 2: severe nausea, fatigue, headache, and body aches
37 2021-01-08 feeling hot Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours.
37 2021-01-08 pain onset of fever 30 minutes post-injection lasting approx. 1-2 hours. Three days later began w/headac... Read more
onset of fever 30 minutes post-injection lasting approx. 1-2 hours. Three days later began w/headache, fever, body aches, fatigue, nausea, diarrhea.
37 2021-01-08 feeling hot, tingling transient chest warmth and tingling in palate. self resolved in 2 minutes. no medications given. mo... Read more
transient chest warmth and tingling in palate. self resolved in 2 minutes. no medications given. monitored 30 minutes after symptoms resolved
37 2021-01-09 pain 1220p- received IM vaccine 1130p- woke up with shortness of breath, chills/rigors, and moderate bod... Read more
1220p- received IM vaccine 1130p- woke up with shortness of breath, chills/rigors, and moderate body aches. Afebrile at this time. Took Tylenol 1000mg PO and went back to sleep. 1/9/21- 945a- Body aches had been improving but progressively getting worse at this time. Tylenol 1000 mg PO taken again. Remained afebrile. 245p- Chills started again, body aches continued. Temp= 100.6. Tylenol 1000mg PO taken. 1/10/21- 630a woke up for the day and continued to have body aches. Temp = 100.9, took Tylenol 1000 mg PO. 730a- reported symptoms to work occupational health and told could return when afebrile without Tylenol and cleared by them. Will continue to monitor symptoms. 730p= Chills and body aches continued. Temp= 101.9. Took Tylenol 1000mg PO and went to bed for the day.
37 2021-01-09 pain Body aches, 1 day
37 2021-01-09 pain in extremity First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned... Read more
First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned to work 1/8/21. Second vaccine dose received 1/8/21 at 11:30am. Muscle aches, chills, and fever started at 19:30 on 1/8/21 and persisted throughout the night retning every 4 hours while alternating Tylenol 650mg every 4 hours and Ibuprofen 600 mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Chills without fever at 4am on 1/10/21. Sweats and right arm localized redness and soreness persisted through 1/10/21 at the time of this report.
37 2021-01-09 pain I developed body aches about 10-11 hours after the vaccine, then fever (100.4F degrees), chills, mi... Read more
I developed body aches about 10-11 hours after the vaccine, then fever (100.4F degrees), chills, mild nasal congestion, and mild headache, which lasted for 1-1.5 days.
37 2021-01-09 dizziness I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the s... Read more
I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the swelling reduced, but isn't gone. About an hour after Benadryl I had some shortness of breath and dizziness that improved with sitting down. I have also had stomach cramping and diarrhea that began aroun noon. Diarrhea symptoms have improved with use of Imodium.
37 2021-01-09 pain in extremity Sore arm, upset stomach and fatigue.
37 2021-01-10 feeling hot, pain in extremity "After about 3 days of a sore arm ( I know this is normal) I started to get the feeling of flushing ... Read more
"After about 3 days of a sore arm ( I know this is normal) I started to get the feeling of flushing with minimal change in color to my face. My brain was telling me my skin felt hot but if you touched it or looked at it you would think maybe my cheeks were a little pink. I could feel this hot sensation on all of my skin on the top half of my body. This happened regularly for about 8 days. I have not felt the hot sensation since 1/3/21."
37 2021-01-10 weakness, dizziness 1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizzi... Read more
1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizziness and weakness 1/9/21 Approximately 4:00 AM had headache/difficulty breathing/fast heartbeat along with the above 1/9/21Approximately 6:00 AM had a fever along with the above but the difficulty breathing and fast heartbeat had passed The remaining of Saturday Am I slept off and on with a terrible headache/difficulty catching my breath at times and taking IBP 2 times throughout the day/drinking plenty of fluids.
37 2021-01-10 pain 100.4 fever Significant body aches Significant Fatigue Headache Joint Pain
37 2021-01-10 migraine, dizziness 2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous ... Read more
2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK5730, Intramuscular at single dose on 17Dec2020 19:00 on right arm for precaution as front line health care worker. Medical history included Hemiplegic migraine. Her mother also had migraines. Concomitant medication included ranitidine hydrochloride (ZANTAC) and H1 and H2 blocker. The patient called to report AE of flushed, persistent extreme dizziness, and a headache that has evolved into a 2 week migraine. She has a history of hemiplegic migraines and was taking and h1 and h2 blocker when she received the vaccine. She was calling on guidance whether or not to receive the second vaccine. She was scheduled for second dose on Thursday, but wanted to speak with someone before she got it to see if it was OK. About 15 minutes after receiving the first dose, she got flushed and extremely dizzy. She had a mild headache when she woke up on 18Dec2020 06:00, which then developed into a severe migraine on 22Dec2020 08:00 that she has had for 2 weeks and dizziness continues. She received it at work and there was no prescriber. She called and left a message with Pfizer but has not heard back from anyone yet about this. She would say the flushed and dizziness would be medically serious because she had allergies and had medication on board. She takes daily allergy medication and Zantac and not sure she would not have had a worse reaction if she hadn't had that on board. She took it every night. She had an H1 and H2 blocker on board. Flushed has improved but the dizziness has stayed constant. She had been treated twice for headache and now they have put her on a Prednisone taper. She got it on her right arm so she could work her arm out. On 22Dec2020, she saw a Neurologist for the Migraine. They gave her Toradol 30 mg and Zofran 4mg injection in office. They were given IM. Then, she had another office visit for urgent care on 02Jan2021, and that was for the exacerbation of the migraine. They prescribed 1 liter of fluids and then another Toradol injection, Zofran injection and Decadron injection. The dose of the Toradol was 30 mg, Decadron was 6 mg, and Zofran was 4mg. These were given IV in urgent care. The patient had no prior vaccinations within 4 weeks. The outcome of flushed/Got flushed was resolving. The outcome of other events was not resolved.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, dizziness, headache and migraine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-10 pain in extremity Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgia... Read more
Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgias sporadic and brief, with fatigue, 36 hours post vaccine, resolution within 12 hours.
37 2021-01-10 pain Brain fog, fever, aches lymph pain
37 2021-01-10 pain Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body ach... Read more
Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body aches. Motrin taken on Saturday and Sunday with improvement.
37 2021-01-10 pain Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chill... Read more
Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chills, headach. Was unable to function due to reaction for 24hours. Said all resolved. Did not seek treatment. Adivsed by Emp Health to not receive 2nd vaccine unless consults with MD for clearance.
37 2021-01-10 weakness For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4... Read more
For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4 hours about 16 hours after shot. Following this, the headache and fatigue remained the rest of the day. Periodic headaches noted in the weeks following. After my second Pfizer Covid shot I experienced nausea, diarrhea, extreme fatigue and exhaustion, malaise 4 days are shot lasting about 24 hours in duration.
37 2021-01-10 pain Got sick on Christmas Day 25th- low grade fever/aches; diarrhea; went on to have shortness of breat... Read more
Got sick on Christmas Day 25th- low grade fever/aches; diarrhea; went on to have shortness of breath and some runny nose and congestion and a lot of fatigue 27th. Went to urgent care - was really tired; runny nose and congestion; Covid test was positive. Regenerome - On the 30th. Tylenol and Ibuprofen.
37 2021-01-10 tingling, numbness Patient developed numbness/tingling in her left ulnar distribution (middle/ring finger, pinky, and o... Read more
Patient developed numbness/tingling in her left ulnar distribution (middle/ring finger, pinky, and outer hand) after getting her vaccine yesterday. The sensation is most intense at the tip of the fingers and lessens proximally. She was vaccinated yesterday at 12:30 pm and it started today around 10 AM. No weakness or fevers. She is currently working and it is not causing any problems. Has RA and has had neuropathies in the past.
37 2021-01-10 tingling Patient experienced flushing, tingling in toes, pounding heart, and elevated BP of 142/80. Patient o... Read more
Patient experienced flushing, tingling in toes, pounding heart, and elevated BP of 142/80. Patient observed, and symptoms resolved without medication.
37 2021-01-10 dizziness Sudden onset dizzyness 5 minutes after immunization.HR Increased 130, decreased to 90 w rest. Transp... Read more
Sudden onset dizzyness 5 minutes after immunization.HR Increased 130, decreased to 90 w rest. Transported to medical Clinic for observation
37 2021-01-10 pain, pain in extremity arm soreness fever chills achiness runny nose
37 2021-01-10 pain in extremity, bell's palsy balls palsy headache arm sore
37 2021-01-10 pain in extremity, bell's palsy balls palsy headache sore arm
37 2021-01-10 lightheadedness extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/... Read more
extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/7 & 12/19 (after both 1st & 2nd vaccine) ZOFRAN & FLUIDS IN E.D. DIAGNOSIS "NEAR SYNCOPE"
37 2021-01-11 slurring, dizziness, pain 1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and b... Read more
1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and belly twitching lips and slurred speech,
37 2021-01-11 feeling of body temperature change, unresponsive to stimuli 16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat ... Read more
16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat on the floor of my bathroom and went unresponsive. Per my husband. My eyes rolled back in my head, my body went limp, and I was moaning. I did not come to for 30-60 seconds despite shaking, calling my name, and sticking his finger in my throat. I came to and was alert and oriented but have no recollection of the incident. EMS was called.
37 2021-01-11 pain 2 days after: headache, body chills, sore throat, and fatigue. Third day: fatigue and body aches
37 2021-01-11 tenderness Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, deve... Read more
Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, developed 3 days after receiving the first vaccine dosage in the series. I have tested negative for covid as of 1/10/21. It was initially thought that I had a skin infection from clipping my nails too short and was prescribed doxyclycline. I saw an improvement within a few days on the antibiotic but them saw a reappearance of the covid toes presenting symptoms on 1/8/21. I have since been told by a physician that I likely have covid toes and not a bacterial infection. I was told to take baby asprin and that is helping to reduce the symptoms. In the past few weeks I have had no symptoms of Covid besides the appearance of covid toes. I understand that covid toes are often a latent symptom and that the timing of the appearance of this symptom could be coincidental. I am mildly concerned that the first vaccine dosage could have caused a flair up of a potential previous covid infection or could have caused the red covid toes symptom itself.
37 2021-01-11 dizziness, migraine Dizziness/nausea, migraine headache, loss of appetite, itchy throat, ear pain
37 2021-01-11 restlessness, pain in extremity, dizziness Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restl... Read more
Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restlessness; feeling unwell; arm pain; This is a spontaneous report from a contactable physician reported for herself. This 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) via intramuscular on 23Dec2020 09:30 AM on left arm at single dose for COVID-19 immunisation. Medical history included chronic kidney disease, HTN (hypertension), persistent proteinuria. No known allergies. Concomitant medication included losartan. The patient did not have other vaccine in four weeks and did not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 24Dec2020, the patient experienced dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, and resulted in Emergency room/department or urgent care. Treatment included paracetamol (TYLENOL). The patient had COVID tested on 28Dec2020 post vaccination, covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=Negative. Outcome of events was recovered.; Sender's Comments: The reported events dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
37 2021-01-11 numbness Facial numbness and headache Have had of history of Bell?s palsy he
37 2021-01-11 pain Fever up to 102; body aches; hip and back joint pain; chills; fatigue; This is a spontaneous report ... Read more
Fever up to 102; body aches; hip and back joint pain; chills; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (lot number: EH9899) on 18Dec2020 17:00 (first dose) then (lot number: EC1284) on 05Jan2021 07:45 (second dose); both intramuscular on the left arm at a single dose for COVID-19 immunization. The patient's medical history included anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021 17:30, the patient experienced fever up to 102, body aches, hip and back joint pain, chills, and fatigue. Outcome of the events was recovering. The events were considered non-serious by the reporter.
37 2021-01-11 pain in extremity, pain I have a headache. My body is feeling fatigue, aching, and very soar. My arms are very heavy , soar... Read more
I have a headache. My body is feeling fatigue, aching, and very soar. My arms are very heavy , soar all the way down to my hands. A Slight cough has even occurred since the vaccine.
37 2021-01-11 pain in extremity, pain I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested,... Read more
I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested, but this morning im still having headache. My body feels aching , chills and very fatigue, slightly soar. A mild mild cough has even occurred. Including Soar Arms all the way down to my hands.
37 2021-01-11 pain I woke up the day after receiving the vaccine with full body aches and severe joint pain, especially... Read more
I woke up the day after receiving the vaccine with full body aches and severe joint pain, especially in the hips making it difficult to walk comfortably. I also had a moderate to severe headache. I was unable to work that day. The pain lessened with ibuprofen but returned later in the day. By the next day, symptoms were a lot better and after 2 days the symptoms completely resolved
37 2021-01-11 pain, weakness Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chill... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chills, body aches, fatigue/weakness, loss of appetite, headache, vision changes, swollen right axillary lymph node (hard, painful) 40hrs-60hrs after injection: fever steady around 101, headache, fatigue, swollen right axillary lymph node (no longer hard, more disperse, still painful) 60+ hrs after injection: swollen right axillary lymph node (disperse, painful, bruising/discoloration) emailed ob/gyn about concern for swollen lymph node turning into mastitis, but referred to PCP
37 2021-01-11 tingling, numbness Received the vaccine on 12/31/20 at 1535 on the left arm. Swollen lymph node start on Friday 01/08/2... Read more
Received the vaccine on 12/31/20 at 1535 on the left arm. Swollen lymph node start on Friday 01/08/20 evening, around 2030 notice a lump on the left under armpit while doing self-breast exam during showering. On 01/09/20 the swollen increase, on 01/10/20 - 01/11/20 the swollen feel every painful, difficult, and comfortable when resting the left arm down, it feels like a golf ball under the armpit. Felt numbness and tingling on the left arm, hand and fingesr. On 01/12/20 lymph node still swollen, but less painful, with less numbness and tingling. Home treatment: Elevated the left arm while applying a warm compress and OTC Tylenol.
37 2021-01-11 feeling hot Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobb... Read more
Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; pulse and BP both were elevated (HR 122 BP 155/80); pulse and BP both were elevated (HR 122 BP 155/80); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (lot number: EL0140), intramuscular on 21Dec2020 10:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 21Dec2020 10:30, it was reported that shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby, the patient started to feel flushed in her face and very warm, and felt her heart racing. The nurse came and took her pulse and BP both were elevated (HR 122 BP 155/80), after three minutes her heart rate and BP came down and normalized again (HR 70 and BP 115/60). Stated that she has never had a similar experience. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The with outcome of recovered on unspecified dates.
37 2021-01-11 pain in extremity, pain Sore arm fever chills body aches headaches fatigue
37 2021-01-11 pain in extremity Sore left arm accompanied with a red bump the size of a quarter, mild headache, and fever of 100.8.
37 2021-01-11 tingling The patient informed me right after she got the vaccine that she felt cold and tingly like after ane... Read more
The patient informed me right after she got the vaccine that she felt cold and tingly like after anesthesia. She also reported a metallic taste in her mouth. She was given water and observed for 30 minutes. I called and left a message for her on 1-12 to see how she was doing.
37 2021-01-11 numbness, tingling, pain in extremity This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; N... Read more
This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
37 2021-01-11 tingling, numbness, dizziness Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and ... Read more
Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and shared her right arm & finger was numb & tingling. Patient became anxious acting, claimed "I feel dizzy & heart racing." Patient monitored, 09:25 heart rate less than 100, states dizziness has resolved, patients respirations even & unlabored skin pink and dry. 09:30 Patient talking in a relaxed manner with co-workers, does continue to complain of "my fingers feel asleep". Pt monitored for over one hour. Patient ambulating without issues out of observation area, skin pink warm, dry, no acute distress reports numbness & tingling resolved, has full range of motion to right arm.
37 2021-01-11 numbness blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fin... Read more
blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fingers and later numb face; Mind fog; This is a spontaneous report from a contactable other HCP. This 37-year-old female other HCP (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1685), via intramuscular at left arm on 02Jan2021 08:15 AM at single dose for COVID-19 immunization. Facility type of vaccine was pharmacy or drug store. Medical history included panic disorder (last attack 2 years prior) and known allergies: latex, Iodine dye. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 02Jan2021 08:15 AM, within a few minutes while still under observation at pharmacy, her blood pressure increased and her pulse. Numb fingers and later numb face. Chest pain presented. She went to ER (emergency room) 3hours later with ongoing symptoms that never resolved until 6 or 7 that evening while still in ER waiting room. Mind fog (02Jan2021 08:15 AM) was currently ongoing. The treatment for events included lorazepam (ADIVAN), diphenhydramine (BENADRYL), ibuprofen. Outcome of event mind fog was not recovered, and the rest of events was recovered/resolved with sequel.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-11 pain body aches 7-8 hours later, worse body aches, chills and rigors 14 hours later for which 600mg motri... Read more
body aches 7-8 hours later, worse body aches, chills and rigors 14 hours later for which 600mg motrin taken, chills and rigors improved one later, body aches continued until 22 hours after vaccination where 600mg motrin taken again, minor body aches and fatigue until 36 hours after vaccination
37 2021-01-11 dizziness, pain body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly ... Read more
body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly around the low hip area but also "all over"; feeling dizzy; elevated BP 155/100; This is a spontaneous report from a contactable consumer for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), Intramuscular in Right upper arm on 04Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included seasonal asthma as a kid and as she got older, it got worse. There were no concomitant medications. She reports the following AE's: "horrible" muscle aches particularly around the low hip area but also "all over", feeling dizzy, elevated BP 155/100 in Jan2021, "pounding head", low-grade fever, body aches 05Jan2021. She received the first COVID vaccine on 16Dec2020 and then the second vaccine yesterday. Now, she doesn't feel fine. The caller clarifies further with the first vaccine, she was fine. She had a sore arm and that's it. With this second vaccine, she doesn't feel fine. She didn't start feeling bad until around 1 a.m. She received the second vaccine yesterday, 04Jan2021. Around 1 a.m., she started feeling not so hot. She confirms she started to experience body aches, making the comment " it's ridiculous, it's my entire body". Also, a headache and low-grade fever. She states these symptoms didn't get really bad or worse until 10 this morning. Outcome of event feeling unwell was recovered on 05Jan2021, of headache, low-grade fever, body aches, was not recovered, of others was unknown.
37 2021-01-11 numbness left sided facial numbness, hyperesthesia, and left eye twitching
37 2021-01-11 pain low grade fever, chills, aches and pains, headache for 18 hours
37 2021-01-11 pain in extremity sore arm, 600mg PO motrin taken one hour after onset
37 2021-01-12 pain 12 hours of headache, body aches, and low grade fever (99.5 - oral)
37 2021-01-12 pain in extremity Arm and shoulder pain to left arm started yesterday shortly after vaccine. When i woke up this morni... Read more
Arm and shoulder pain to left arm started yesterday shortly after vaccine. When i woke up this morning it was very painful and i had a limited range of motion to that arm. Both symptoms have improved slightly over the course of today. Also the vaccine was injected higher than the recommended two fingers below the acromian process in my arm.
37 2021-01-12 pain Body aches, chills, fever of 99.7 lasting a couple of days
37 2021-01-12 pain Day after my second vaccine I had body aches, muscle and joint aches, neck stiffness, headaches and ... Read more
Day after my second vaccine I had body aches, muscle and joint aches, neck stiffness, headaches and was nauseated. I hurt so bad that I did not want to move. I Routinely took Ibeprofen every 6 hours and phenergran to help with my symptoms. These symptoms only last one day. Which was the day after my second vaccine.
37 2021-01-12 pain Experienced general aches, headache, soreness and irritation at the injection site as well as muscle... Read more
Experienced general aches, headache, soreness and irritation at the injection site as well as muscle pain in the shoulders and back. Symptoms began around 2000 on 01/09 and subsided overnight between 01/10 and 01/11.
37 2021-01-12 pain, pain in extremity Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolve... Read more
Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolved in 1 day)
37 2021-01-12 feeling cold Fatigue, hot and cold flashes, headache, sore throat, mild joint pain, Nausea
37 2021-01-12 lethargy, pain, feeling hot, feeling cold Following vaccination, I had a headache for few days along with some pain on injection arm. The hea... Read more
Following vaccination, I had a headache for few days along with some pain on injection arm. The headache continued and soon some fatigue and tiredness accompanied it for 7-10 days following vaccination. Then ten days after, I had an increase in symtpoms that included heightened fatigue, loss of appetite, feeling "cold"/ "hot" (no fever), and abdominal pain with nausea and some diarrhea. Two weeks after vaccination, I had an increased of fatigue and not feeling well, accompained by a fever of (101.5 F) and chills, sore throat, and lethargy. My symptoms of fever, chills, sore throat, body aches, congestion, and fatigue remained over the next few days and soon included chest pain and some increase work of breath. With two negative Covid tests through work, it was recommended I go to see a physician, who instead sent me to Immediate Care. There I had an EKG which showed sinus bradycardia and they sent me to ER due to my symptoms of chest pain and shortness of breath. At the ER, multiple tests were run to negative results. ER Physician suspects that some of my struggles could be related to Covid vaccine but that I also may have caught an non-Covid virus on top of it which led to acute bronchitis.
37 2021-01-12 dizziness Immediately after IM injection of the vaccine, patient start with an ascending muscular pain through... Read more
Immediately after IM injection of the vaccine, patient start with an ascending muscular pain through shoulder and neck (left side). Didn't take any analgesic and went to sleep that night as usual. When she woke up next day felt dizzy and fainted. Husband held her and give alcohol to smell, what caused patient to respond. Took her BP and found it low (100/60). The person lay down and rested for an additional 2 hours and then continues her day as usual.
37 2021-01-12 numbness, pain in extremity Patient reported sore arm on night of vaccination. Around 36 hours later, started to develop lymph ... Read more
Patient reported sore arm on night of vaccination. Around 36 hours later, started to develop lymph nodes swollen under left arm. It is causing numbness in left arm from elbow to pinky finger.
37 2021-01-12 pain, dizziness Roughly 12 to 16 hours after receiving the vaccine I stated with some fatigue and body aches. I took... Read more
Roughly 12 to 16 hours after receiving the vaccine I stated with some fatigue and body aches. I took tylenol and motrin twice during the 12 hour shift at the scheduled times. I was working night shift when this happen and came home and went to bed 24 hours after receiving the vaccine. The time I went to bed had fatigue, headache, body aches with neck and back pain. Took tylenol and motrin before going to sleep. When I woke up at 4pm, 31 hours after receiving the vaccine I had, sore throat, head congestion, severe body aches and headache. I attempted to get up since I was scheduled to work at 7pm and then got dizzy. I took tylenol and motrin, put a heating pad on my back, drank some hot tea and went back to bed for the night. Woke up at 7:30am almost 2 days after receiving the vaccine still with headache, body aches and fatigue. The sore throat and head congestion seem to have subsided. Took more tylenol and motrin and went back to bed. Still at this time feel just tired and body aches, mostly in the neck and back.
37 2021-01-12 pain about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & ac... Read more
about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & acetaminophen), severe muscle aches, could barely move or sleep About 24 Hours after vaccine - same symptoms continued but developed very painful golf ball size lump under left armpit (lymphnode) same side as injection; around noon - the fever started to break but remained elevated (101.7-101F); remaine din the low 100's all day with being on ibuprofen/acetaminophen and still achy/headaches but not unbearable About 48 Hours later - woke up at 3 AM with another 101 F - went to work but left around 9 AM not feeling well (may just have been from exhaustion from not sleeping well the previous 2 nights); lymphnodes still swollen and painful; 101 F around 7-8 PM About 72 hours later - no fevers, feeling better; developed rash on left arm below injection site (red, slightly raised, warm to touch, painful to touch but not itchy), lymph node still painful but not as big About 96 hours later - rash same size, slightly swollen, painful to touch; lymph node smaller in size but still painful to touch
37 2021-01-12 pain body aches, fever. called in sick to work.
37 2021-01-12 pain nausea; vomiting; significant amount of diaphoresis; sudden onset of joint pain in upper torso invol... Read more
nausea; vomiting; significant amount of diaphoresis; sudden onset of joint pain in upper torso involving fingers, elbows, and shoulders; Pain progressed into lower body; enlargement of the right supraclavicular lymph node; This is a spontaneous report from a contactable pharmacist(patient). A 37 years old female patient received second dose BNT162B2, Intramuscular on 05Jan2021 11:30 at the 37 years old at Arm Right at single dose for COVID-19 immunization. The medical history included Asthma and Seasonal Allergies. The concomitant medications were not reported. The patient previously took fist dose BNT162B2 on 16Dec2020 12:00 PM, Intramuscular at Arm Right at 37 years old for COVID-19 immunisation. The patient developed sudden onset of joint pain in upper torso involving fingers, elbows, and shoulders approximately 11 to 12 hours post immunization on 05Jan2021 23:00. Pain progressed into lower body throughout the night on 05Jan2021 23:00. The next morning, the pain increased to a point which caused severe nausea and vomiting on 06Jan2021. The patient received Toradol and Zofran to ease symptoms. After which, her husband was called to transport me home from work. The next 24 hours, the patient rested. During which, the patient experienced a significant amount of diaphoresis on 06Jan2021. Forty-eight hours later, my symptoms are improving. I am sore, but functional. The only new occurrence is enlargement of the right supraclavicular lymph node in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not Allergies to medications, food, or other products. The outcome of events was recovering. The information on the batch number has been requested.
37 2021-01-13 dizziness, pain, weakness "Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minu... Read more
"Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minutes post vaccine, my tongue went numb for approximately 30 minutes, then it resolved. 6 hours post vaccine I became very dizzy and flushed and began to feel achy. The following morning I felt well enough to come into work but then felt increasingly weak, achy, and tired and had to go home at 12pm. All side effects were resolved by 5pm. "
37 2021-01-13 pain in extremity, dizziness, feeling hot, pain 1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body... Read more
1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body aches 1/13-elevated heart rate, SOB, dizziness--slightly better than 1/12 1/13-symptoms subsided
37 2021-01-13 pain in extremity 1/11/2021 - stomach pain, headache, exhaustion, arm pain 1/12/2021- fever 100.0 and diarrhea for 3 d... Read more
1/11/2021 - stomach pain, headache, exhaustion, arm pain 1/12/2021- fever 100.0 and diarrhea for 3 days Took ibuprofen
37 2021-01-13 pain 1/13-malaise, mild headache, chills, joint pain, body aches, low grade temp (99.7) 1/14 worsening ex... Read more
1/13-malaise, mild headache, chills, joint pain, body aches, low grade temp (99.7) 1/14 worsening exhaustion, body aches, head/neck pain, chills, afebrile.
37 2021-01-13 pain Body aches; Fever; Chills; Nausea; This is a spontaneous report from a contactable healthcare profes... Read more
Body aches; Fever; Chills; Nausea; This is a spontaneous report from a contactable healthcare professional (HCP), the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 06Jan2021 at 09:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) and known allergies possibly penicillin related drugs. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 at 21:00, the patient experienced body aches, fever, chills, and nausea. No treatment was provided for the events body aches, fever, chills, and nausea. The outcome of the events body aches, fever, chills, and nausea was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
37 2021-01-13 pain Fatigue; Severe body aches; This is a spontaneous report from a contactable nurse (patient). A 37-ye... Read more
Fatigue; Severe body aches; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in the right arm on 04Jan2021 17:30 at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe body aches and fatigue on 06Jan2021 04:00 (also reported as about 36 hours after injection). Treated at home with rest, increased fluids, and Ibuprofen 800mg. The patient fully recovered at 72 hours post-vaccine. Outcome of the events was recovered in Jan2021. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
37 2021-01-13 pain Fever (100), body aches, headache, chills, fatigue
37 2021-01-13 pain Fever, body aches, HA mild diarrhea , fatigue . Tylenol with improvement.
37 2021-01-13 pain Headache, 101.4 fever, chills and achy sensation
37 2021-01-13 vertigo I had vertigo, unsteady gate, nausea, vomitting, difficulty with visual tracking.
37 2021-01-13 numbness Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patie... Read more
Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patient reports that her left cheek went numb. Patient reports the feeling came back the next day. Patient reports extreme soreness, to the point of not being able to use her arm. She also reports "excruciating" pain on her entire right side of the body that radiated into her knees and hips. Patient was seen by her PCP on 1.11.21. Patient was prescribed a steroid at the time. On 1/14, the patient returned back to work and describes her pain as tolerable now.
37 2021-01-13 tremor Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not ... Read more
Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not feeling well. I had to stay home from work the day after the vaccine, I stayed in bed all day with a space heater on to 90 degrees in my bedroom just to get rid of the chills, I took Motrin 800 mg around the clock, Zofran as needed and I drank a lot of water.
37 2021-01-13 pain body aches and chills 1/14 all day
37 2021-01-13 pain body aches, chills, nausea, headache, fatigue, took Tylenol
37 2021-01-13 pain, weakness headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 2... Read more
headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 24 hours to reduce symptoms of aches (alternated every 4 hours). took two days for symptoms to reduce completely
37 2021-01-14 feeling cold 20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD HEART PALPUT... Read more
20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD HEART PALPUTATIONS , CALLED THE NURSE . EKG WAS NORMAL .. Blood pressure was 130/99 which is higher than normal ..Provided IV FLUIDS . HEADACHES, NASUEA ,CHILLS.
37 2021-01-14 pain 2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, naus... Read more
2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, nausea on Sunday morning at 02:30. This continued the rest of the day but was improved with Aleve. Woke up on Monday feeling well. Monday afternoon started developing a rash on bilateral thighs and arms. The rash was itchy and inflamed. Took Benadryl 12.5mg the next 2 nights. Wednesday the rash had improved, still pinkish but not red. Thursday the redness had resolved, but was still itchy. The itching continues today, but very mild.
37 2021-01-14 pain in extremity At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progre... Read more
At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progressed to myalgias in my back, especially lower back, neck, and right arm. At 2300, I started to have fever/chills, up to 39 C orally. This only partially responded to Tylenol. I was not able to sleep. At 2:30 am I noticed an unusual headache, 8/10, as well as bilateral eye pain on Moving eyes side to side as well as sensitivity to light. Headache was mostly frontal, which came and went every few minutes until exactly 11:38 am on 1/14/2021, when the fever and myalgias very suddenly got significantly better. Almost exactly 24 hrs to the minute after injection. On 1/15/2021, I still have significant pain in my left arm, swelling, redness and, now, itching at the injection site. My lower back still hurts.
37 2021-01-14 dizziness Awoken by chest pain at 1am on 1.15.2021. Went to ER - unsure if anxiety attack, heart attack or rel... Read more
Awoken by chest pain at 1am on 1.15.2021. Went to ER - unsure if anxiety attack, heart attack or related to COVID vaccination on 1.12.2021. Also complains of dizziness, and nausea. Cardiac workup performed. Ativan relieved her symptoms. No remarkable findings and patient was discharge back home at 06:30 1.15.2021.
37 2021-01-14 weakness, dizziness, pain Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This i... Read more
Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This is a spontaneous report from a contactable health care professional, the patient. A 37-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), in the right arm on 30Dec2020 13:00 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Pharmacy or Drug Store. Medical History include drug allergy to sulfa. Concomitant medication included Microgestin, Biotin and Prenatal Vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 31Dec2020 , the patient experienced Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea. No treatment was received given for the event. The clinical outcome of Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea was recovering.
37 2021-01-14 dizziness Employee received second dose of Pfizer COVID vaccine on 1/13/2021 at 1400. Employee had a syncope e... Read more
Employee received second dose of Pfizer COVID vaccine on 1/13/2021 at 1400. Employee had a syncope episode on 1/14/2021 around 1300. Employee called the nurse on 1/15/2021 at 0840 to report syncope. Employee denies any current dizziness, nausea or vomiting.
37 2021-01-14 pain Fever (T-Max was 100.9); body aches; fatigue; This is a spontaneous report from a contactable nurse ... Read more
Fever (T-Max was 100.9); body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 at 10:30 (at the age of 37-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not receive any other mediations within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (temperature maximum (T-Max) was 100.9), body aches, and fatigue on 18Dec2020 at 13:30. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: T-Max of 100.9 on 18Dec2020 and nasal swab: negative on 04Jan2021. The patient did not receive any treatment for the events. The clinical outcome of fever (T-Max was 100.9), body aches, and fatigue was recovered on 19Dec2020 at 22:30.
37 2021-01-14 pain Fever max of 104; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patien... Read more
Fever max of 104; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration; first dose (lot EH9899) on 16Dec2020 19:00 (07:00 P.M.) and then the second dose (lot EJ1685) on 06Jan2021 08:00 A.M.; both at a single dose on the left arm as COVID vaccine. Medical history included hypertension; known allergies to sulfa, milk, and iv contrast. Concomitant medications were not reported. The patient had known allergies to doxycycline, morphine, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (TYLOX), and ceftriaxone sodium (ROCEPHIN). The patient experienced fever max of 104 with Motrin and Tylenol 2 days, body aches, fatigue, all on 06Jan2021 19:00 that were assessed as non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The events resulted to a doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. She was not diagnosed with COVID-19 prior to vaccination. She had been tested for COVID-19 since the vaccination in which lab data included nasal swab Send off pending results and rapid test was negative, both on 08Jan2021. Therapeutic measures were taken as a result of fever max of 104 while treatment was not received for the rest of events. The outcome of the events was recovering.
37 2021-01-14 pain Full body aches and fever 12 hours after vaccine, lasted 2 hours, relieved by acetaminophen and ibup... Read more
Full body aches and fever 12 hours after vaccine, lasted 2 hours, relieved by acetaminophen and ibuprofen. Daily headaches and nausea since second dose administration. Ibuprofen and acetaminophen PRN for headaches. No treatment for nausea. Headaches and nausea are still ongoing.
37 2021-01-14 feeling hot I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel my heart beati... Read more
I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel my heart beating but wasn't irregular, I took a shower I realized I had a rash on my arms and thighs (front), did not hurt or itch, pinprick bumps, it felt like sandpaper. I had facial flushing, felt hot and turned red, I took pepcid and benydryl, I went to sleep because that was the end of my shift . The rash stuck around for 1.5 weeks for the rash to go away . I woke up 6 hours after and felt fine I only had the rash and I went to occumed to document my symptoms and everything was fine after that
37 2021-01-14 pain Lymph node pain, body aches lasting approximately 24 hours, unable to sleep
37 2021-01-14 pain Nearly immediate onset of pain. Vaccine administered very, very high in my arm. Range of motion ef... Read more
Nearly immediate onset of pain. Vaccine administered very, very high in my arm. Range of motion effected. Seen by orthopedic specialist and showing symptoms of bursitis. How much of the vaccine went into my muscle vs. my bursa? Do I need a 3rd booster?
37 2021-01-14 tingling, numbness Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returne... Read more
Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returned at 0632 to vaccine clinic stating that she was having numbness and tingling to jaw and lips and left ear. Vitals were obtained: 115/73, HR, 74, O2 Sat: 97% on RA. Patient denies any SOB of difficulty breathing. Patient has no noted welts or redness noted. 0635: Patient was given 25 mg of Benadryl, PO and patient is drinking her coffee. 0640: patient sitting up in chair, patient denies any tingling and or numbness to jaw, lips, and left ear. Patient states " I can not believe I am feeling so much better. I have no numbness at all." 0702: patient feeling much better, and denies any SOB, edema, numbness and or tingling. Patient vitals: B/P: 113/58, HR: 76, O2 Stat: 97% on RA. Patient did ambulate out of clinic with out issues. Advised patient on signs and symptoms to look out for and when to seek medical attention. Patient verbalized understanding.
37 2021-01-14 tingling, pain Patient reported "tingling" sensation, bilateral upper extremities after second dose of Pfizer COVID... Read more
Patient reported "tingling" sensation, bilateral upper extremities after second dose of Pfizer COVID-19 vaccination. Sensation radiated to neck area. Also, reports "tingling" in toes. No there other symptoms. She did have this reaction with the first dose, subsided in within 2 hours. Patient was discharged to home in stable condition.
37 2021-01-14 pain, migraine Severe Migraine 10/10 lasting 24 hours (felt like my head was going to explode ice applied to my ey... Read more
Severe Migraine 10/10 lasting 24 hours (felt like my head was going to explode ice applied to my eyes and next), Nausea, Body aches lasting 24 hours ( could not move without help pain 8/10), congestion, fatigue.
37 2021-01-14 pain in extremity, pain Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for ap... Read more
Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for approx. 36 hrs.
37 2021-01-14 numbness, pain Stated neck stiffness, numbness of both upper extremities, and body pain.
37 2021-01-14 pain in extremity, restlessness, weakness Very sore left arm the next day after injection. The next day after injection had chills, hot flashe... Read more
Very sore left arm the next day after injection. The next day after injection had chills, hot flashes, and low grade temperature of 99. Was restless and unable to sleep on the night of the 13th. Also had lower back pain as well as low energy and overall tired feeling. These symptoms lasted until the later morning of the 14th. Ibprofun was taken.
37 2021-01-14 numbness, dizziness muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain... Read more
muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain, insomnia, faint chest pain, numbness right arm and leg, diarrhea, wheezing (off and on), fatigue.
37 2021-01-14 pain rigorous chills, temp of 101.6, headache, body ache and fatigue
37 2021-01-15 feeling hot The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I ... Read more
The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I asked her if she had any history of anaphylaxis. She said she did to morphine. Her bp was 119/74 with a pulse of 94. She said her nose was starting to get itchy, her ears and scalp were itchy, and her eyes were blurry. She had red blotches all over her neck and chest. She said her throat was tight. She was able to swallow the water she requested. I gave her 50mg of benadryl. She had no visible signs of being unable to breathe. I explained to her we could call 911. She reported she had no insurance. She said she was on her lunch break at the hospital and wanted to get back. She did walk back across the street unassisted. Clinical observer, followed her over just to verify she made it in the building. She ended up checking herself into the ER instead of returning to her shift.
37 2021-01-15 vertigo, balance disorder Within 2 minutes post vaccination i started feeling loss of sense of myself. I could not pinpoint if... Read more
Within 2 minutes post vaccination i started feeling loss of sense of myself. I could not pinpoint if i felt dizzy or vertiginous. Felt like i was off balance and i was super vernous to walk. Vertiginous episodes come and go with peaks for at least 10 times. The whole episode lasted 4 hours until i felt going back to myself. I was provided water, 1 L and orange juice, there was epi available. No anaphylactic symptoms, no shortness of breath. I drank 1,5 L of fluids and then my BP was checked 120/80, HR 80s. I note that i never felt syncopal, no diaphoresis, nausea, nor darkened vision and i was fully interactive with the bystanders. Note, i am a critical care intensivist so i had full grasp of the issue but i could now quite describe the sensation of this acute loss of instability. The best way to describe this was vertigo. Similar episode occured at the first vaccine with COVID, occured after 10 minutes and lasted no more than 30 seconds. I didnt report that then because i thought it was just dehydration.
37 2021-01-16 pain, numbness Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and laste... Read more
Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and lasted approximately 45 minutes. Headache, Fever (Tmax 101.8), aches, chills started at 0330 day after vaccine given 1400 day prior to symptoms , ended by 2100 day after vaccine.
37 2021-01-19 feeling hot 37yo female with PMH HTN and allergy to pencillin (hives) had no reported reaction to dose #1 of COV... Read more
37yo female with PMH HTN and allergy to pencillin (hives) had no reported reaction to dose #1 of COVID-19 Pfizer BioNTech dose #1. Post vaccination with dose #2, patient c/o feeling warm, flushed, and appeared anxious stating "This is the way I get." No supportive treatment nor antidote given. Patient states she feels better. Under observation by clinic team members. Ambulated to door without assistance with no c/o dizziness. Discharged to self.
37 2021-01-19 pain 8 hrs after vaccine staff started to have chill and bodyache and last upto 75 hrs. Around 50hrs sta... Read more
8 hrs after vaccine staff started to have chill and bodyache and last upto 75 hrs. Around 50hrs started to have headache and it disappeared at about 80 hrs. Would like to report the symptoms, reactions. Feels well today and has been back to work.
37 2021-01-19 dizziness, pain Chills, Body ache, Headache, Dizziness, Fever.
37 2021-01-19 tingling, feeling cold Experienced some tingling in the left arm starts at the injection site and radiates down to the fing... Read more
Experienced some tingling in the left arm starts at the injection site and radiates down to the fingers. can feel the sensation in all 5 fingers, fingers feel cool to the pt but her hands feel of equal temp to the examiner, was able to use her phone to text
37 2021-01-19 lethargy, pain Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and mo... Read more
Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and moderate pain. Injection site reaction is approximately 2cm x 3cm.
37 2021-01-19 pain, dizziness Severe body aches, chills, fever 103, fatigue dizziness, headache - symptoms lasted 2days, the thir... Read more
Severe body aches, chills, fever 103, fatigue dizziness, headache - symptoms lasted 2days, the third day I had diarrhea and nausea.
37 2021-01-19 feeling hot Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours... Read more
Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours later I had flu like symptoms along with a blistering rash on my neck, face and scalp..with a few spots on my chest and back. These started to heal 5 days after injection, then started to resurface. On Day 3 I started getting short of breath and intermittent chest pains accompanied by a heart rate ranging from 110 to 126. I developed a severe headache and fatigue.
37 2021-01-20 pain Lupus flare, intractable pain, chest pain; patient received prolonged infusion of ketamine
37 2021-01-21 pain 12 hours - Slight Nausea 24 Hours - Moderate Nausea 24-36 hours - Moderate Chills/Aches By 36 hours... Read more
12 hours - Slight Nausea 24 Hours - Moderate Nausea 24-36 hours - Moderate Chills/Aches By 36 hours I felt 100% normal again.
37 2021-01-21 pain DEVELOPED BODY ACHES, FEVER, CHILLS, AND HEADACHE LASTING 24 HOURS.
37 2021-01-21 pain, pain in extremity Fatigue, achiness, headache, sore arm for about 24 hours
37 2021-01-21 tingling, numbness I received my 2nd dose of the Pfizer covid-19 vaccine to my left arm on Monday 1-11-21 around 1330. ... Read more
I received my 2nd dose of the Pfizer covid-19 vaccine to my left arm on Monday 1-11-21 around 1330. Following this, I experienced pain at the injection site until 1-12-21 when the pain spread to my left axilla. I also experienced notable swelling to the left axilla and numbness and tingling that radiates down my left arm and into my left pinky and ring fingers. My first dose was also administered to my left arm with only soreness at the injection site experienced. I have not previously experienced any reactions to vaccines in the past.
37 2021-01-21 tingling, numbness On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gr... Read more
On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gradually moved up to the waistline area. Then total numbness, heaviness in legs, making it difficult to walk. There is also a raised, red rash that burns. Her symptoms are not better.
37 2021-01-21 pain STARTED FEELING CHILLS, BODY ACHES, HEADACHE, AND NAUSEA. LOSS OF APPETITE. TOOK TYLENOL EVERY 4 HRS... Read more
STARTED FEELING CHILLS, BODY ACHES, HEADACHE, AND NAUSEA. LOSS OF APPETITE. TOOK TYLENOL EVERY 4 HRS AND PLENTY FLUIDS.
37 2021-01-21 pain in extremity starting in the evening of the day of the vaccine, began experiencing pain in my left pinky. The f... Read more
starting in the evening of the day of the vaccine, began experiencing pain in my left pinky. The following day (1/20), the pain was worse leaving me unable to do daily tasks. It increased through the day at work (1-handed work) to the point of being unable to use 3 fingers without excruciating pain. On 1/21, saw a neurologist who diagnosed parsonage turner's syndrome due to the covid vaccine.
37 2021-01-24 numbness Initially she was fine during 15 minutes observation period. Facial redness/itching developed around... Read more
Initially she was fine during 15 minutes observation period. Facial redness/itching developed around 15-20 minutes after shot on 1/7/21. No rash anywhere else on body. Numbness in face. Headache. Per patient, co-nurses told her she had facial swelling. No trouble breathing. No throat swelling. No cough. Got famotidine and Benadryl. blood pressure was elevated (228/120). She felt better after about 2 hours.
37 2021-01-24 dizziness Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a sp... Read more
Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a spontaneous report from a contactable nurse reported for self. This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 12:00 PM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The patient had no COVID prior vaccination. The patient had none known allergies. The patient medical history included hypertension/ gastric sleeve 2020. The patient concomitant mediations included metoprolol 100mg once a day. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 18-Dec-2020 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced extremely large lymph nodes, chills, fevers, Constant headache and dizziness sensation, mental fog. The events onset date was reported 08-Jan-2021 20:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. The COVID test post vaccination (COVID test type Nasal Swab, COVID test name COVID/flu AB by PCR) resulted Negative on 11-Jan-2021. The patient received no treatment. The outcome of events was recovering. Information on the Lot/batch number has been requested. Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported mental fog and the administration of the suspected vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-24 facial paralysis suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous ... Read more
suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at 0.3ml single injection in the left arm on 22Dec2020 09:00 for covid-19 prophylaxis. Medical history included persimmon fruit allergy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced tingling in the left side of her tongue on 22Dec2020, the event was reported as serious per medically significant, suspect that it may be bell's palsy on an unspecified date. The adverse event was not required a visit to emergency room or physician office. Caller was an employee health nurse that reported that she had an employee that received the first dose Covid-19 vaccine on 22Dec2020 and as they were administering the vaccine, the patient developed tingling in the left side of her tongue. The caller said that the patient reported that the tingling was still there. She said that the patient was concerned that it might cause her to get bell's palsy. Caller wanted to know if this was this common and whether she could move forward with getting the 2nd dose of the vaccine. The caller said that the patient received the vaccine in her left arm. The caller said that the patient reported that the tingling in her tongue was mild and not stopping her from eating and she was not having any respiratory issues. Caller said that the only allergy that the patient has was to Persimmon fruit. The side effect mentioned is not necessarily Bell's palsy since the characteristic eye drooping is not present. The outcome of events for tingling in the left side of her tongue was not resolved, for suspect that it may be bell's palsy was unknown. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No relevant tests. Drug result was related.; Sender's Comments: The causality between the reported tingling in the left side of her tongue, which was suspected that it may be Bell's Palsy and the administration of COVID-19 vaccine, BNT162B2, cannot be denied, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-25 lethargy, pain I was puking, lethargic, headache, body aches from Dec. 30- Jan. 2. On Jan 2, 2021 I went to the ER.... Read more
I was puking, lethargic, headache, body aches from Dec. 30- Jan. 2. On Jan 2, 2021 I went to the ER. I was given sodium chloride, nausea med and an allergy med.
37 2021-01-25 numbness numbness of left side of face/scalp; hyperesthesia of left face/scalp/ear; left sided submandibular ... Read more
numbness of left side of face/scalp; hyperesthesia of left face/scalp/ear; left sided submandibular lymphadenopathy; This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular on 08Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.The patient had no known allergies. It was unknown if patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 for covid-19 immunization on 18Dec2020 (lot number unknown), via intramuscular route in the left arm. The vaccination was administered in the hospital. On 08Jan2021, the patient experienced numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment as gabapentin for the reported events. The patient was not tested for covid post vaccination. The events numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy were not recovered. Information on lot number/batch number was requested.
37 2021-01-26 pain in extremity Arm soreness
37 2021-01-26 restlessness From midnight on the 26th through approx 2pm on the 26th: headache, restlessness, intermittent nause... Read more
From midnight on the 26th through approx 2pm on the 26th: headache, restlessness, intermittent nausea, nasal congestion then runny nose and overall fatigue feeling.
37 2021-01-26 pain in extremity Its been a little over 2 weeks; Since the 2nd dose I have had swollen lymph nodes, head aches and fe... Read more
Its been a little over 2 weeks; Since the 2nd dose I have had swollen lymph nodes, head aches and feeling fatigue. I have not been well. My Axilla Lymph nodes became so swollen that it has caused me to have urgent ultrasound and even a lymph nodes biopsy. Including, I have taken Tylenol Extra Strength for headaches and even Advil Migraine. Also - Since the Injection My right Arm has continued to be soar and still a bit swollen. 01/27/2021 .
37 2021-01-26 pain in extremity Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours aft... Read more
Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours after vaccination administered Sore arm - lasted 4 days Back pain - lasted 2 days Chills and abdominal cramping lasted 2 hours
37 2021-01-26 tremor Woke up with headache, Temp = 101, chills, whole body shaking during night 1/7/21 in am temp = 99, n... Read more
Woke up with headache, Temp = 101, chills, whole body shaking during night 1/7/21 in am temp = 99, no further chills
37 2021-01-26 pain in extremity itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles);... Read more
itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
37 2021-01-28 dizziness, pain Fever 102.5, body aches, chills, HA, dizziness
37 2021-01-28 pain Flu like systems, body aches, Fever, woke her out of sleep, sore lymph nodes still swollen, fever, t... Read more
Flu like systems, body aches, Fever, woke her out of sleep, sore lymph nodes still swollen, fever, terrible headache. Had to take off work 01/27/21 couldn't get out of bed.
37 2021-01-28 weakness On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or an... Read more
On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or any other significant health issues. No medication was taken at time of vaccination or prior to appointment. Was advised to seek care. Went to urgent care and diagnosed with costochondritis. Given Toradol shot and chest pain began relieve within 30 min. 1/29 reports no chest pain, but still has weakness and persistent headache.
37 2021-01-28 dizziness Persistent shortness of breath; Chest pain; Runny nose; Dry cough; Dizzy; This is a spontaneous repo... Read more
Persistent shortness of breath; Chest pain; Runny nose; Dry cough; Dizzy; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the second dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm, on 07Jan2021 09:15 at a single dose for COVID-19 immunization in a hospital. Medical history included narcolepsy from an unknown date and unknown if ongoing and ongoing persistent shortness of breath from an unknown date. No known allergy. Concomitant medication included armodafinil, sertraline hydrochloride (ZOLOFT), and dextroamphetamine (DEXAMFETAMINE). The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 in right arm for COVID-19 immunization at age 37 years old. The patient had no COVID prior to vaccination. On 07Jan2021, the patient experienced shortness of breath, chest pain, runny nose, dry cough, dizzy. The patient had 2 ER visits and admission, and ongoing work up. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. The patient received albuterol and alprazolam (XANAX) as treatment. The patient underwent covid test post vaccination: Nasal swab on 11Jan2021 and on 12Jan2021 with both with result negative. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events shortness of breath, chest pain, runny nose, dry cough and dizzy. The patient's underlying ongoing shortness of breath and psychiatric disorder treated by sertraline may also be contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-28 dizziness Pt. developed feeling of flushing and dizziness immediately after receiving the vaccine , then C/O p... Read more
Pt. developed feeling of flushing and dizziness immediately after receiving the vaccine , then C/O palpitations and chest tightness a few minutes later at 6:14pm. After vital signs were found to be stable and improving with reassurance her complaints resolved without medication or treatment.
37 2021-01-28 migraine, pain pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not m... Read more
pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not move; fever; increase blood pressure; chest tightness; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist. A 37-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140, expiration date: Mar2021), via Intramuscular on left arm on 02Jan2021 at 18:00 at 0.3 mL, single for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. The patient previously took Tylenol one hour prior to the vaccination on 02Jan2021 at 1 tablet by mouth. Patient complained of nausea, brain fog on 02Jan2021 at 06:20 pm. Pharmacist recommended to admit ER for safety and to monitor. Patient received the injection at 6pm. Patient was recommended by Pharmacist to admit ER for safety. Patient decided to admit ER at 10 pm. No other symptoms were reported from patient. The patient was admitted to hospital on 02Jan2021 and was discharged on 03Jan2021. While at the hospital, patient informed that she had fever, increased in blood pressure, and chest tightness on 03Jan2021 (reported as mid night). Patient admitted to hospital on 10 pm and was discharged the next day with ibuprofen/Tylenol/ zofran and continue to monitor for symptoms. After discharged, while at home, patient informed about migraine, swollen arm, pain at injection site and body that she could not move at 9:00 am on 04Jan2021. Patient informed that she admitted to hospital again about the pain on arm/body. The patient received 1 dose of 0.3ml and before it was possible that the vaccine was not mixed with sodium chloride prior to administration, an error due to mixture to communicate clearly adequately between our colleagues. Patient received the vaccine at 6 pm on 02Jan2021. After speaking with our colleague about 15 minutes ran to check on the patient if she was feeling okay. Patient complained feeling a bit nausea, brain fog, no other symptoms. Patient stated that she was okay. They stayed back at the store to keep track of patient to admit to ER after her shift at 10 pm. Patient informed she had fever, chest tightness, increase blood pressure at the hospital, then was discharged the next day with ibuprofen/tylenol/Zofran. The following day during at home patient complained at migraine, swollen arm, Pain at the injection site and could not move due to the pain. Patient decided to admit back to hospital for additional information about her pain. They contacted patient again after 3 days, patient informed. She was better and had returned to work on 13Jan2021. The outcome of the events was recovered on 11Jan2021. The pharmacist considered the events were related to suspect product Covid-19 by Pfizer.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea, brain fog, pain on arm/body, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-28 unresponsive to stimuli stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy;... Read more
stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown. Information about lot/batch number has been requested.
37 2021-01-31 pain Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non... Read more
Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (left arm) on 23Dec2020 (14:45) at single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, nausea, fever, chills, body aches, and fatigue on 24Dec2020 (12:00AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
37 2021-02-07 weakness, balance disorder Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; na... Read more
Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; nausea/vomiting while sitting or attempting to stand-2 days; leg cramps/charlie horses- 3-5 days; general weakness in arms and legs- weeks/current; difficulty with fine motor movements in fingers and weakness in arms and hands-current
37 2021-02-10 dizziness dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a con... Read more
dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a contactable other healthcare professional (HCP). A 37-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date: unknown), intramuscular (right arm) on 24Jan2021 at 10:30 at a single dose for COVID-19 immunization. Medical history was not reported. Allergies to medications, food, or other products was unknown. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: unknown), on 03Jan2021 at 10:15AM, intramuscular (left arm) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache, tachycardia, chest pain, chills and fever on 25Jan2021. Treatment for the events included IV fluids, Benadryl, Antivert, Benadryl, Toradol and Reglan. The events required Emergency Room Visits and Physician Office Visit. The events were resolving at the time of the report.
37 2021-02-16 seizure At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pres... Read more
At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pressure of 227/153; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 01Feb2021 10:00 at single dose on right arm for COVID-19 immunisation. Medical history included high blood pressure. Historical vaccine included 1st dose of BNT162B2 on 11Jan2021 08:00 am via intramuscular on right arm for COVID-19 immunisation. Patient was not pregnant. Concomitant medication included labetalol and HCTZ. At 04:00 am of 02Feb2021, after second vaccine patient had a seizure. Patient was found non-responsive with a blood pressure of 227/153. Emergency room was visited. Patient have no history of seizures and it was concluded by PCP that this was an adverse response to the vaccine. Treatment was received. Outcome of the events was recovered/resolved with sequel. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events seizure, loss of consciousness and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-02-21 pain After my second dose of the vaccine I had typical flu-like symptoms (fever 101.5, chills/shivering, ... Read more
After my second dose of the vaccine I had typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea) yet also developed acute and severe shortness of breath. My flu-like symptoms resolved within 48 hours yet my breathing difficulties continued and worsened. I was treated in the Emergency Department on 1/12, 1/19 and 1/20 (work up negative for covid, pulmonary embolism, infection, cardiac abnormalities). It feels as though I am having intractable diaphragm spasms that are forcing my exhales out at the end of my breath cycle. I have lost 10lbs and have been essentially incapacitated for 6 weeks. I have been evaluated by head and neck (no vocal cord dysfunction), speech pathology (no swallowing difficulties), pulmonology (no lung specific issues) and am awaiting a neurology consult.
37 2021-02-21 pain in extremity I was suppose to receive my 2nd Covid vaccine dose on Thursday 2/11 at the Drive Thru site; but my a... Read more
I was suppose to receive my 2nd Covid vaccine dose on Thursday 2/11 at the Drive Thru site; but my appointment got cx?d due to our weather. So it got rescheduled to Thursday 2/18 at 12p. My 1st dose was Moderna. I gave the lady my card and a Moderna sticker is clearly on it and readable. She came back to my vehicle and gave my 2nd injection; apparently she gave me Pfizer (I didn?t know that until she handed my card back to me). She handed my card back; I looked down at it and saw it said Pfizer. I said, ?What just happened? I got Moderna the 1st time why does my 2nd one say Pfizer?? She didn?t have anything to say. She then left immediately to go get someone else to talk to me. This person said I wasn?t the 1st person this has happened to. It still has the same mRNA molecules in both vaccines. She also said I shouldn?t need another dose of any vaccine. I should be okay even though I got the different vaccine. I was also told by her that when the sites run out of Moderna or Pfizer; then they are giving (employees and the public) the opposite one that they have on hand. (I don?t know how true this is but this is what I was told). After this happened I contacted my Director and my Manager and informed them of what happened. They both said I did nothing wrong Director contacted our Employee Health office. Then the Employee Health Nurse called me to check on me and get some information. Nurse called me again on Friday to see how I was and to take more information to fill out an incident report. Then she was going to talk to the Head Pharmacist again and get back to me about what he said. I haven?t heard back from her yet. I?m still upset because that incident should never have happened (and it?s bad that it happened to an employee). Our employees need to slow down. They need to make sure their name badge is visible (the lady giving mine- I never saw her badge). Then they need to verify what vaccine they have in their hand with the pt/person again before they inject it to avoid another situation from occurring like mine). What I?m more upset about is: there is no research as far as what having 1 dose of Moderna and 1 dose of Pfizer is going to do to my body?? Am I protected at all? Am I more protected? Will I have bad side effects later? We don?t know. That?s the scary part. I just don?t want this to happen to another employee or anyone else. So far the only thing I had happen to me since the injection is a painful sore left arm. I have no idea what effects I may have later...??.... from having Moderna in my system; then Pfizer.
37 2021-02-21 feeling hot Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. S... Read more
Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. She then returned after 12 minutes complaining of feeling hot and flushed and throat, face and arms itching. Her O2 sat was 99% on room air, heart rate 71, respiratory rate of 18. She was given Benadryl 50 mg PO and after 10 or 15 minutes stated she did not have any of noted symptoms any longer.
37 2021-02-21 weakness Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that starte... Read more
Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that started approximately 12 hours after vaccine. I felt weak, achy and tired. Symptoms resolved around 36 hours after vaccine.
37 2021-02-22 dizziness 0843: POST VAC. ADMIN. C/O: DIZZINESS, NAUSEATED, SLUGGISH FEELING. VS: 98.3, P: 78, R: 18; BP... Read more
0843: POST VAC. ADMIN. C/O: DIZZINESS, NAUSEATED, SLUGGISH FEELING. VS: 98.3, P: 78, R: 18; BP: 128/70. ESCORTED, AMB. TO EHS.
37 2021-02-22 pain Low grade temp. Body aches, head ache, and fatigue
37 2021-02-22 pain On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into t... Read more
On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day. I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again. A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.
37 2021-02-22 lightheadedness Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on stan... Read more
Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on standby and took vitals: 129/89 BP, Resp 16, lungs clear on auscultation, pulse 104, blood sugar 69. Patient reported she had not eaten since 12:00 pm. Patient reported at 6:50 pm that her nausea was improving. At 7:00 pm, patient had a near-syncope event and was diaphoretic. She was placed in a wheelchair and taken to a private area. She appeared struggling to focus, but was responsive to questions. She developed a rash on her chest and an ambulance was called related to dermal, CNS, and GI symptoms. On ambulance arrival, Diphenydramine 15 mg IV was given and patient was transported to ER.
37 2021-02-22 unresponsive to stimuli Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident.... Read more
Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident. Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder. Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider. Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.
37 2021-02-28 weakness 2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomac... Read more
2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomach; dehydrated; weakness; loss of appetite; chest tightness; feel like a panic attack; This is a spontaneous report from a contactable Other Healthcare Professional, the patient. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly on 19Jan2021 at 11:00 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient has no allergies to medications, food, or other products. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) on 30Dec2020 at 19:00 intramuscularly as a single dose in the right arm for COVID-19 vaccination after which the patient experienced fatigue, muscle soreness in neck and shoulders and vaccination site pain. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MIDOL) and ibuprofen(MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Jan2021 at 23:30 she began to experience fever, extreme chills, all over muscle aches, loss of taste for a day ,extreme fatigue, upset stomach, dehydrated, weakness, loss of appetite, chest tightness that would come and go making it feel almost feel like a panic attack. She further stated that she has lingering side effects such as extreme fatigue, muscle aches and chest tightness after day three of receiving this second dose that comes and goes. Currently on day seven and still have those lingering three side effects. Fatigue has been extreme at times. The patient did not receive any treatment for the events. The clinical outcomes of the events Fever, extreme chills, myalgia, loss of taste, extreme fatigue, upset stomach, dehydration, weakness, loss of appetite, chest tightness and panic attack were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107223 Same reporter, Same product, Same patient, same and different events (First Dose)
37 2021-02-28 migraine HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migrain... Read more
HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migraine; Left index finger petechiae; had an insect bite; lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile); temperature was 101 F; Acne flare-up; no withdrawal bleeding and she was on oral contraceptive pill (OCP)/withdrawal bleeding 3 days late; woke up at 2:00 AM and 2:35 AM because of the tenderness rolling over and she had to take central analgesia to be able to sleep; puffy face; tenderness at the site of injection; Constipation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on the left arm, on 06Jan2021 15:45, at single dose, for covid-19 immunization. The patient has no medical history; unknown if there were any allergies. Concomitant medications included oral contraceptive pill (OCP) and multivitamins. The patient had no Covid prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the Covid vaccine. She took pre-vaccination analgesia. The vaccine was given at the hospital. On 06Jan2021 (day 0) she experienced tenderness at the site of injection. She also experienced constipation on 06Jan2021. However, she couldn't "comment" about temperature since she was taking NSAIDs. She woke up at 2:00 AM and 2:35 AM on 07Jan2021 (day 1) because of the tenderness rolling over and she had to take central analgesia to be able to sleep. On 07Jan2021 she experienced tenderness at the site of injection and; puffy face but it wasn't angioedema. Her O2% was "99-98% repositioning" on 07Jan2021. She still had constipation and still couldn't comment about temperature since she was taking NSAIDs. On 08Jan2021 (day 2) she had an acne flare-up; and no withdrawal bleeding and she was on oral contraceptive pill (OCP). For the constipation she started on OTC fiber gum. On 09Jan2021 (day 4) she experienced lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile) which hadn't resolved. She still was experiencing constipation. Her temperature was 101 F on 09Jan2021. On 10Jan2021 (day 5) she had withdrawal bleeding 3 days late and heavier and longer than usual, migraine, constipation, and left index finger petechiae because on "23/11" she had an insect bite on 10Jan2021. On 11Jan2021 (day 6) her lymphadenopathy on the left posterior cervical (1x1 cm tender freely mobile) hasn't resolved; she still had migraine and was now back to regular bowel habit. On 15Jan2021 (day 10) she had HSV 1 "eruption and subli". She received treatment (also reported as symptomatic treatment) for all these adverse events. At the time of the report, she recovered from constipation on 11Jan2021 with lasting effects; while she also recovered from all the other remaining adverse events on Jan2021 with lasting effects. She has not been Covid-tested post-vaccination.
37 2021-02-28 pain in extremity Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fa... Read more
Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered. No follow-up attempts are needed. No further information is expected.
37 2021-02-28 pain in extremity arm started to get sore; This is a spontaneous report received from a contactable consumer (patient)... Read more
arm started to get sore; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 12:00, at single dose, for covid-19 immunization, at the workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 17:00, the patient's arm started to get sore and continued to get more sore throughout the evening. It was much better when she woke up in the morning of 27Jan2021, and the pain was fully resolved by 17:00 on 27Jan2021. No treatment was given for the event. The patient recovered from the event on 27Jan2021 at 17:00.
37 2021-02-28 pain she feels body soreness and difficulty moving at a fast pace; she feels body soreness and difficulty... Read more
she feels body soreness and difficulty moving at a fast pace; she feels body soreness and difficulty moving at a fast pace; It just that my muscles are too weak. It was 'like it is after half a mile of swimming'; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9262, expiry date was unknown) via an unspecified route of administration, on 26Jan2021, at single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient reported that she received first dose of vaccine Tuesday. She did not feel sick or as if she has the flu per her report. She felt body soreness and difficulty moving at a fast pace in Jan2021. She would like to know if it will be okay for her to get the second dose of vaccine. Patient stated that my muscles are too weak in Jan2021. Patient also reported that, I have no fever, I have no cough, I don't feel sick. It just that my muscles are too weak. It was 'like it is after half a mile of swimming' (not clear over the call). I was reading all the papers and it says that it is normal as of one of the symptoms. I was just wondering how long it will take to be that away." No treatment was given to the events. Outcome of the events was reported as unknown.
37 2021-02-28 lethargy soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from ... Read more
soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 16:00, the patient experienced soreness at injection site, lethargy after the vaccine, and headache. The patient received ibuprofen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
37 2021-03-10 migraine, tremor Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingl... Read more
Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingling lips and shaking. EMS was on scene at clinic immediately removed me from car and checked vitals, BP was high 176/94, took by ambulance to ER at Medical Center. Treated in ER for 4.5 hours. Developed migraine, received benadryl, steriods,and medicine for the migraine. Sent home told take benadryl for 2 days and do
37 2021-03-17 pain, weakness, tingling *Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gab... Read more
*Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gabapentin *Extreme exhaustion and sleepiness *Body ache: Tylenol *Headache- Tylenol *Extreme thirst *Nausea: Ondansetron *Vomiting *Constipation: Senna with Docusate Sodium *Weakness *Some difficulty breathing
37 2021-03-21 pain pain is severe and disabling; severe myalgia to legs started next day after 2nd dose, then to should... Read more
pain is severe and disabling; severe myalgia to legs started next day after 2nd dose, then to shoulders, arms, with mild headache. Never resolved after 2 weeks. gabapentin gave temporary relief but pain is severe and disabling.; mild headache; This is a spontaneous report. A contactable physician reported that a 37-year-old non-pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), first dose via intramuscular on 06Feb2021 as single dose for COVID-19 immunization, received (BNT162B2, solution for injection, Batch/Lot Number: EM9810) second dose via intramuscular on 27Feb2021 as single dose for COVID-19 immunization and patient was non-pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included endometriosis, and patient had allergy for meloxicam, NSAIDs, blepharospasm and angioedema. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medication included norethindrone acetate (NORETHINDRONE ACETATE) taken for an unspecified indication, botulinum toxin nos (BOTULINUM TOXIN NOS) taken for an unspecified indication on 08Jan2021 to an unspecified stop date. The patient experienced pain was severe and disabling, severe myalgia to legs started next day after the second dose, then to shoulders, arms, with mild headache on 28Feb2021. Never resolved after 2 weeks. Therapeutic measures were taken as a result of pain is severe and disabling (pain), severe myalgia to legs started next day after second dose, then to shoulders, arms, with mild headache. never resolved after 2 weeks and gabapentin gave temporary relief, but pain is severe and disabling. (myalgia), mild headache (headache). The outcomes of the events was not recovered. Follow-up information has been requested.
37 2021-03-22 dizziness Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items... Read more
Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items as well they all tasted, off; This is a spontaneous report from a contactable Other HCP. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration single dose left arm on 10Feb2021 07:30 for covid-19 immunisation. The patient received the first dose (Lot # EL3249) left arm on 20Jan2021 07:30 AM. Medical history included type 2 diabetes mellitus. Concomitant medication included metformin, insulin glargine (LANTUS). The patient experienced dizziness on 10Feb2021 20:00, chills on 10Feb2021 20:00, everything I eat and drink tastes like chemicals/i tried other people food items as well they all tasted, off (ageusia) on 10Feb2021 20:00. The events outcome was not recovered.
37 2021-03-22 dizziness, vertigo, migraine, pain in extremity, pain Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue... Read more
Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue, dizzy light-headed, loss of voice, sob, diarrhea, and sore arm. No outcome still ongoing testing and seeing specialists.
38 2020-12-31 numbness, tingling, feeling cold 25 minutes after the vaccine was given, I felt a rush of cold go down my left arm and had a cold sen... Read more
25 minutes after the vaccine was given, I felt a rush of cold go down my left arm and had a cold sensation and then tingling/numbness to my left wrist and left hand for about 36 hours until it gradually subsided.
38 2020-12-31 pain in extremity Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second ti... Read more
Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second time I had severe chills around 1:45 pm in the afternoon. And My right arm has soreness.
38 2021-01-03 tingling, numbness 40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. T... Read more
40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. The right site of my body started tingling. Burning , red, swollen and itching at the injecting site.. Area around injection site was the size of a softball very painful, itchy, burning sensation, swollen, and red. I took Benadryl
38 2021-01-03 pain in extremity, feeling hot Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expe... Read more
Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expected/shortness of air; Coughing/cough got worse; She is covid positive/Tested positive for COVID 19; She is covid positive/Tested positive for COVID 19; Shortness of breath/Shortness of breath was reported as worsened/feels winded; Tachycardia; Has been sick ever since; Felt like she was in a fog, on a cloud, heavy and out of it; She felt hot and weird but had no fever; Headache; Burning sensations in her legs; Extreme fatigue, want to go to bed; headache went away and she felt like the congestion was clearing up some; Arm was sore; This is a spontaneous report from a contactable ICU nurse (patient [Registered nurse ADN]) via Pfizer-sponsored program. A 38-year-old female patient received single dose of BNT162B2 (lot number: EK5730) , via an unspecified route of administration (right arm) on 16Dec2020 20:30 for immunization (for front line health care worker). Medical history included allergies; acid reflux; patent foramen ovale (PFO); supraventricular tachycardia (SVT) without treatment, vitamin D low and ongoing smoker. The patient had no other history/family history. Concomitant medication included loratadine (CLARITIN) taken for at least 5 years for allergy, famotidine from Dec2020 for acid reflex, and vitamin D taken for 5 or more years for vitamin D low; all given orally and were ongoing. The patient had no other prior vaccines within 4 weeks of Covid vaccination. Patient had been taking Covid tests on and off due to her immunocompromised daughter. On 15Dec2020 she took the PTR that took three to four days for results; she tested negative for Covid and was completely asymptomatic. She then received the COVID 19 vaccine 16Dec2020. Her test was positive for COVID 19 on 18Dec2020 and she had been sick ever since. She received the vaccine at the hospital where she works. The vaccine was not administered at facility. She further reported she was fine after getting the COVID 19 vaccine. Her right arm was sore/ started to hurt about four or five hours later on 16Dec2020 but then was fully after 24 to 48 hours. She started to feel sick on 18Dec2020 (Friday evening). States she went to bed Friday morning after the night shift. She felt fine, better than normal. That same day (18Dec2020) she woke up at 1700 and felt like she was in a fog, on a cloud, heavy and out of it. She walked around for a while and that sensation didn't go away. She felt hot and weird but had no fever. Then at 1830 she got the alert on her phone that told her she was positive for COVID 19. She started to feel other symptoms on 18Dec2020 including headache, shortness of breath, tachycardia, burning sensations in her legs; extreme fatigue, wanting to go to bed that persisted from Friday to Sunday. Then on 20Dec2020, Sunday afternoon, her headache went away and she felt like the congestion was clearing up some. Mentions she did have a fever (onset date unspecified) with a high of 99.6 Fahrenheit; but it went back down to 99.0 Fahrenheit (date/s unspecified). On 20Dec2020 the patient experienced coughing. On 21Dec2020 (Monday) she started coughing more but states her O2 was fine and her breathing was okay. However, when walking around she felt winded like she has exerted herself more than expected. She then clarified that on 21Dec2020, she experienced shortness of air and the cough got worse but it has now plateaued. She did call her HCP and they were holding off on treatment at the time. No investigation assessment was performed. The patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness nor did she require supplemental oxygen or receive mechanical ventilation. No preexisting diseases worsened during the SARS-CoV2 infection. The patient considered shortness of breath, and tachycardia as serious: medically significant while the events headache, burning sensations in her legs, fatigue, Coughing, and feels winded were considered as not serious. The events headache, shortness of breath, tachycardia, burning sensations in her legs, fatigue, Coughing, and feels winded were ongoing at the time of reporting. Shortness of breath worsened. The patient recovered from arm was sore on an unspecified date in Dec2020; and was recovering from tachycardia, sick, headache and congestion. The outcome of felt like she was in a fog, on a cloud, heavy and out of it; felt hot, and fever was unknown while not recovered for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-03 pain in extremity I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chill... Read more
I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chills around 3-4pm fever was low grade stayed around 99.8 the following day which was the 23 of dec i had a headache all day and felt fatigued on the 24 i felt normal. My arm was sore VERY sore for about 4 days. I did test positive for covid on 11/2/2020 with moderate symptoms
38 2021-01-04 numbness, tingling Approx. 15 min after dose 1 onset numbness/tingling sensations from bil elbow to hands, and bil knee... Read more
Approx. 15 min after dose 1 onset numbness/tingling sensations from bil elbow to hands, and bil knee to feet. Denied loss of sensation described as pins and needles. Seen in the Emergency Department and released: Received IV fluids and all labs were within normal limits.
38 2021-01-04 slurring Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a sponta... Read more
Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscularly on 29Dec2020 08:00 at left arm at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. Patient previously took metronidazole (FLAGYL) and experienced allergy. Patient experienced headache, hypertension, face flushed, extremely tired, slow motion, and slurred speech on 29Dec2020 09:30. Treatment was not received for these events. Outcome of the events was resolving.
38 2021-01-04 pain in extremity I felt fine initially just so soreness of my arm. The next day I started with the chills and a littl... Read more
I felt fine initially just so soreness of my arm. The next day I started with the chills and a little bit of the headache, I just kinda figured it was a response to the vaccine and did not think much of it. Through the night I had fever (100.8F), chills and headache. I took some Excedrin and Wednesday morning I felt ok. I decided to go to work but the screening told me because I had fever in less than 24 hrs I could not go to work I had to report to the COVID hotline. They sent me to get tested because of the fever. I got tested at hospital and was tired the rest of the day but no fever and the next day I was ready to go to work but I had to wait for the test results that would come 24hrs later. The test came back positive. So I could not return to work until yesterday.
38 2021-01-04 pain, pain in extremity In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms su... Read more
In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms subsided by day 7. On day 10 (12.31) began to again experience arm pain and new rash over injection site. Pain spread to opposite arm and then became generalized. Pain worse in armpits. Rash turned into raised bullseye over injection site prompting MD visit. COVID tested completed and was negative blood work sent and is pending. I was started on Pepcid/benedrly and doxycycline.
38 2021-01-04 dizziness, tingling, tremor, feeling of body temperature change It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In ... Read more
It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In about 10 min I felt very hot in my face, back and felt like I was going to pass out. My heart was racing, it was about 130. My BP initially was 139 and then 160 after that. I never passed out but I felt those waves with a tingling to my face and my neck as I was going to pass out and I started shaking and my heart was racing and my BP was up and it lasted about 45 min before it started going down. They gave me some Ibuprofen at the Employee health and they kept observing me and it started getting better after 45 min. I still felt the waves of feeling flush and hot and cold and very fatigued.
38 2021-01-04 pain Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morn... Read more
Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morning, January 3rd, woke up around 10-11am body aches, headache, fatigue, swollen lymph node under left arm pit, took 3 ibuprofen around 12:00pm. Headache and body aches subsided slightly but never fully gone. Around 6:00pm -7:00 low grade fever and chills, took 3 ibuprofen around 8:00pm. Body aches and fatigue continued to Monday, January 4th, but was reduced in severity, took 3 ibuprofen around 10:00am. All symptoms with exception of swollen lymph node and heat/swelling/pain at injection site are now gone by Tuesday January 5th.
38 2021-01-04 dizziness PTE PRESENTA MAREOS Y BP ELEVADA. POR LO QUE REQUIERE SER EVALUADA POR MD DE TURNO.
38 2021-01-04 dizziness Received vaccine on 1/4/21 at 12:50. On 1/5/21 at 3:00 called nurse line to report fever of 101.8, ... Read more
Received vaccine on 1/4/21 at 12:50. On 1/5/21 at 3:00 called nurse line to report fever of 101.8, chills, cough, dizzy with standing.
38 2021-01-04 feeling hot, lightheadedness Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administ... Read more
Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administration), flushed feeling, pale, near syncope followed by nausea and dry heaving. Lasted 30 mins. Felt fatigued and mild headache for next 24-48 hours.
38 2021-01-04 dizziness per pt. after covid vac. shot was given ,she fell palpitations and lightheadedness after few mins. ... Read more
per pt. after covid vac. shot was given ,she fell palpitations and lightheadedness after few mins. receiving the vac.
38 2021-01-04 numbness, tingling tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to ... Read more
tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 26Dec2020 11:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was given at nurse's hospital vaccine clinic. Medical history included narcolepsy with cataplexy. Concomitant medication in two weeks included venlafaxine hydrochloride (EFFEXOR SR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took naproxen and erythromycin; and experienced drug allergy. On 26Dec2020, the patient stated "At about 1150 my tongue started to get a little bit of numbness and tingling. I didn't really feel nervous but I thought maybe some type of anxious reaction. So I thought I'd give it just a little time and over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks and up underneath my eyes on both sides. I was not feeling anxious about the vaccination. I didn't have any trouble breathing or difficulty swallowing. It felt like Novocain that was wearing off like after you have dental work done. I decided to take 25mg Benadryl to see if it went away. And it definitely got better about 25 minutes after I took the Benadryl. Within an hour I would say it was 95% gone. Still just like a trace numbness on my cheeks. When I woke up this morning (27Dec2020) I noticed the facial numbness had completely resolved." The adverse event start time also reported as 11:45 AM. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 27Dec2020. Information on the Batch/Lot number has been requested.
38 2021-01-05 feeling hot 20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it ... Read more
20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it was tingling, patient felt flushed and warm and stated she "just didn't feel right" patient evaluated by provider - claritin 20mg given, vitals taken after another 30 minutes of being observed patient stated she"felt better"-hives gone
38 2021-01-05 feeling hot About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, ... Read more
About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, I began experiencing mild itching on my face, chest and upper body (no hives or rash) and my face was flush. At about 40 minutes, began experiencing nasal congestion, runny nose and and a slight tickle in the back of my throat. A few hours later, all symptoms resolved.
38 2021-01-05 pain Chills, shivering, body aches, joint aches , treated with Motrin with improved symtpoms
38 2021-01-05 numbness Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, f... Read more
Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-01-05 dizziness, pain in extremity I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour ma... Read more
I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour mark, I developed extreme dizziness and I received medical care at ER on the 23rd of December.
38 2021-01-05 tingling, migraine Migraines, right side of face swollen, nausea, tingling
38 2021-01-05 tingling, numbness Numbness and tingling on the injection site and the left side of your face. Also reports a metallic ... Read more
Numbness and tingling on the injection site and the left side of your face. Also reports a metallic taste in her mouth
38 2021-01-05 tenderness Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localize... Read more
Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localized reaction of tenderness and slight redness. No other symptoms. Provider was placed in the observation area and given and ice pack for the area and made aware that we do have oral Benadryl available. After about 2-3 min Genoveva alerted me that she was now having some itching/scratchiness to the back of her throat and requested Benadryl. 25 mg PO with water was administered and she was immediately escorted to the ED for evaluation with an RN, per protocol.
38 2021-01-05 feeling cold, pain Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this toda... Read more
Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this today.; Chest pain; Headache; Body aches; Fever; Chills; fatigued; feels cold; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (lot number: EL3246), via an unspecified route of administration, at deltoid right, on 30Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included chronic asthma from an unspecified date, stomach surgery a year and a half ago, sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has had asthma stuff since she was very young. Is relatively healthy. No family medical history. No relevant tests. The patient's concomitant medications were not reported. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. The patient previously took flu vaccine on 01Oct2020 and experienced fatigued, tired, and sore arm like she got kicked in the arm by a horse. It was reported that received COVID-19 vaccine yesterday (30Dec2020). Been having some chest pain. Started a couple hours after receiving the COVID-19 Vaccine. Chest pain doesn't whole heartedly go away. Gets more intense and then relaxes. Wants to know if this is common or something she just has to deal with. Doesn't know if this is stomach pain. Had stomach surgery a year and a half ago. Sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has been taking heartburn and gas medications. Chest pain is not going away. Wants to know if this is common. Tried to look online and only found common side effects. Her husband looked it up and two people died from a heart attach after receiving the COVID-19 Vaccine. She is getting older, but is not that old. Caller works in behavioral health. Had an instant headache. Clarified chest pain: Is always lingering in the background. Doesn't fully go away. Comes and goes in waves. Gets intense and relaxes. Chest pain was pretty sharp this morning and it made her short of breath. Doesn't know if it was the pain that took her breath away. Occurred at 10:00. Indication: Has older people she takes care of. Her mother is super frail and has dementia. Her uncle is elderly and has heart issues. Wants to do her part so she doesn't catch it. No further details provided. In regards to the two people who had heart attacks and died after COVID-19 Vaccine, caller has no patient identifiers or NDC/Lot/Exp to provide. Stated this people were in the UK and the information was just something her husband read on the internet. Also experienced body aches, fever, and chills between 14:30 and 15:00 yesterday, 30Dec2020. Is super fatigued. Doesn't know if she is febrile, hasn't checked temperature. Still feels cold and has chills today. Does not have a headache today. It was also reported that fatigued and tired with Flu Vaccine (historical vaccine). Sore arm like she got kicked in the arm by a horse. Her arm felt like this today (31Dec2020). Therapeutic measures in response to chest pain is received, treatment included heartburn and gas medications. Gas medication is Equate brand Simethicone Extra Strength Gas Relief (NDC: 49035-487-02, Lot:H22016, Exp: Sep2022) at 125mg liquid-gel. Heartburn medication is Equate brand Cimetidine 200mg tablet (NDC: 49035-820-72, Lot: Doesn't know if lot number is OJE2445C or 0JE2445C, Exp: Jun 2022). Stated writing is so tiny. Gas and heartburn medication has not helped with chest pain. The outcome of the event chest pain was not recovered, of the other events were unknown.
38 2021-01-05 pain Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fev... Read more
Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fever/chills, body aches (arthralgias, myalgia), headache, site injection pain (which was immediate upon injection, I bled- not a good administration), polyuria/difficulty sleeping overnight, I felt like I was very sick with the flu.
38 2021-01-05 pain Whole body aches, chills, fatigue
38 2021-01-05 pain in extremity, pain Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and ge... Read more
Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and generalized body aches began about 1230, temperature taken at that time was 99.0. Continued with work and by 1530 began to have increased myalgias and pain in knees, took temperature 100.0 and took 400mg Ibuprofen. Fever broke, began to have diaphoresis and felt body aches were gone with exception to left arm. Woke up 1.6.21 and with pain in left axilla and noted to have tender and swollen lymphnodes. Took another 400mg Ibuprofen about 0830. Muscle pains remain to arm, axilla and neck.
38 2021-01-05 dizziness, pain in extremity dizziness, fatigue, arm soreness, myalgia
38 2021-01-05 pain in extremity, pain pain all over the body, swelling of neck, axilla and arm, pain on left side of arm.
38 2021-01-06 pain in extremity, pain AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIEN... Read more
AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIENCED EXTREME PAIN, COULDN'T LIFT HER ARM OR MOVE THE FINGERS ON THAT ARM. IT ADVANCED TO HER NECK AND BACK, SEVERE HEADACHE, STATING IT FELT LIKE SHE HAD BEEN HIT IN THE HEAD WITH A HAMMER. SHE ALSO FELT HEART POUNDING AND HAD CHEST PAIN. DESCRIBES ALL THE PAIN AS THROBBING. SHE RAN FEVERS (HIGHEST WAS 100.3) AND HAD CHILLS. DIDN'T GET OUT OF BED UNTIL 11:30 THE FOLLOWING MORNING.
38 2021-01-06 facial paralysis Bell?s Palsy
38 2021-01-06 pain EE reports, HA and body aches that improved with Tylenol.
38 2021-01-06 numbness Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of... Read more
Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of my tongue tingled . and pressure on my right eye and I was not able to focus. I have headaches that come and go. my back is achy since last week and yesterday half of my body felt numb.
38 2021-01-06 dizziness I think there should be a warning against drinking alcohol after the vaccine . Had the same amount a... Read more
I think there should be a warning against drinking alcohol after the vaccine . Had the same amount as I usually do, 2 mixed drinks, but felt exaggerated affects and dizzy. Speaking to others- 1 glass of wine felt like 2-3.
38 2021-01-06 pain in extremity, numbness Post Second dose, my right arm is numb from elbow down to the proximal side of my hand. My pinky fin... Read more
Post Second dose, my right arm is numb from elbow down to the proximal side of my hand. My pinky finger and ring finger are numb. Restless arm. Pain is all the way up to my neck.
38 2021-01-06 tingling, numbness right 2nd toe numbness that spread to great toe and then midfoot. The next day the left foot was nu... Read more
right 2nd toe numbness that spread to great toe and then midfoot. The next day the left foot was numb. Some paresthesias in hands but that quickly resolved. Right foot still feels "asleep" most of the time, regardless of positioning. No weakness.
38 2021-01-07 numbness 1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over th... Read more
1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks, and underneath my eyes on both sides. Because it kept slowly progressing I took 25 mg oral Benadryl. About 20 minutes after the Benadryl I noticed that my tongue didn?t feel or look as swollen. Within an hour I would say 95% better. I just had some trace numbness on my cheeks bilaterally. Symptoms returned again about 12 hours later. Again took Benadryl, this time 50 mg. All symptoms have resolved
38 2021-01-07 dizziness Burping. nausea, and dizziness
38 2021-01-07 pain Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable... Read more
Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 21Dec2020, the patient experienced chills, aches, sweating, dyspnea, wheezing, and fatigue. The events are considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
38 2021-01-07 dizziness, feeling hot FLUSH IN FACE, HEAT ON FACE, HEADACHE, DIZZINESS
38 2021-01-07 pain Fever, injection site tenderness, body aches, joint pain, severe headaches, fatigue
38 2021-01-07 numbness I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart ra... Read more
I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-01-07 dizziness Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof o... Read more
Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof of mouth, sob, constricted throat, altered sense of taste. Episode lasted for about 30 minutes. I sat and rested, focusing on my breathing and not panicking. I did not seek medical attention.
38 2021-01-07 pain Low grade fever (99.5), aches, chills, nausea. Arm didn?t hurt as bad as 1st vaccination, but other... Read more
Low grade fever (99.5), aches, chills, nausea. Arm didn?t hurt as bad as 1st vaccination, but other symptoms were worse.
38 2021-01-07 pain Low grade fever and body aches
38 2021-01-07 dizziness Received vaccine 1/5/21. On 1/8/21 she felt dizzy and nauseated and fatigued. Blood pressure, pulse,... Read more
Received vaccine 1/5/21. On 1/8/21 she felt dizzy and nauseated and fatigued. Blood pressure, pulse, temperature, O2 level all within normal limits.
38 2021-01-07 numbness Reported numbness on the left side of face after receiving first dose of vaccination and left deltoi... Read more
Reported numbness on the left side of face after receiving first dose of vaccination and left deltoid. Was transferred to emergency department at local hospital.
38 2021-01-07 facial paralysis, slurring Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, ... Read more
Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, bad taste in mouth then lost sense of taste. Pain on the right side of face/jaw area. Trouble speaking. Went to ER at hospital then transferred to another ER.
38 2021-01-07 dizziness, feeling cold While waiting ini observation area pt reported "not feeling well" was given water and asked to stay ... Read more
While waiting ini observation area pt reported "not feeling well" was given water and asked to stay for aditonal amoutn of time. SOrtly after she reported "feeling like i am goinog to pass out" . Lightheaded dizzy, no other physical complaints. Pt is cool, lips pale.
38 2021-01-07 tingling Within 3 minutes of receiving vaccine, associate became flushed, tachycardic, tingling to chest and ... Read more
Within 3 minutes of receiving vaccine, associate became flushed, tachycardic, tingling to chest and abdomen, and weakness of legs. She was observed for 35 minutes by Drs. during this time period. Symptoms resolved in entirety during this time. Associate was later contacted by Dr. via phone follow-up 1 hour after leaving vaccine clinic and associate reports symptoms continue to be resolved and did not reoccur.
38 2021-01-07 pain Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. I... Read more
Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
38 2021-01-07 tingling nausea, tingling in hands, states slight airway restriction, Benadryl 25mg given po at 11:40am, Puls... Read more
nausea, tingling in hands, states slight airway restriction, Benadryl 25mg given po at 11:40am, Pulse 72, O2 SAT 100%, Patient was observed for 20 minutes, patient left at 12pm stating feels better returning to work.
38 2021-01-07 dizziness, pain severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of... Read more
severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of breath; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK9231; Expiration date was not reported), via an unspecified route of administration in the left arm on 29Dec2020 at 09:15 (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took cefzil and experienced allergies. On an unspecified date, the patient experienced severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches. The patient was seen in the emergency department for the events. Therapeutic measures for the events included medications and IV fluids; both not further specified. The outcome of the event severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches was recovered. No follow up attempts are possible. No further information is expected.
38 2021-01-08 feeling hot About 15 minutes after the injection I felt a warm sensation throughout my body and it went away imm... Read more
About 15 minutes after the injection I felt a warm sensation throughout my body and it went away immediately. About 10 minutes after that, my throat started feeling scratchy/itchy/tingling, then my tongue and lips. After about 10 minutes it went away. I felt ok so I left the vaccination area and went back to my department I work in. For several hours the same symptoms came and went in waves, lessening over time. At 8:30pm the same day, I took 25 mg PO Benadryl to feel safe while sleeping. I felt fine the next day and reported it to the pharmacist in the vaccination clinic. I never felt like my airway was compromised.
38 2021-01-08 dizziness Dizziness & Tachycardia Narrative: Participant C/O dizziness upon ambulation shortly after completin... Read more
Dizziness & Tachycardia Narrative: Participant C/O dizziness upon ambulation shortly after completing a 15 minute observation period. Noted tachycardia with a heart rate of 137. Pt transported VIA wheelchair to the Emergency room triage area for further evaluation.
38 2021-01-08 pain Headache, body aches, weird back pain . Took ibuprofen
38 2021-01-08 dizziness, balance disorder, pain I was to dizzy to drive myself home. Vomiting, headache, off balance, nausea, runny nose, horrible... Read more
I was to dizzy to drive myself home. Vomiting, headache, off balance, nausea, runny nose, horrible body aches.
38 2021-01-08 pain in extremity Left armpit swelling with pain and soreness
38 2021-01-08 pain Severe sore muscles, headache, body ache, fatigue
38 2021-01-08 dizziness Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, ever... Read more
Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, everything went black and felt like I was going to pass out. Husband got to me and laid on the floor. Never passed out completely, but it was a very weird and odd feeling. Felt better after about 20 mins. Have felt great since. So did not go to primary care physician but felt the need to report.
38 2021-01-09 tingling Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat fel... Read more
Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat felt like it was slightly swollen, chills, head felt foggy, instant fatigue
38 2021-01-09 pain Developed body aches, fever and malaise at approximately 12 hours after vaccination that lasted unti... Read more
Developed body aches, fever and malaise at approximately 12 hours after vaccination that lasted until 36 hours post vaccination
38 2021-01-09 pain in extremity, pain Fatigue, body aches, arm pain, chills
38 2021-01-09 pain Fever 102 with chills, body ache, headache. Fever started 24 hours post vaccination. Subsided with ... Read more
Fever 102 with chills, body ache, headache. Fever started 24 hours post vaccination. Subsided with ibuprofen then relapsed 48 hours post vaccination.
38 2021-01-09 pain in extremity, pain Headache, body aches, arm soreness, nausea, chills
38 2021-01-09 tremor, feeling cold, pain I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respi... Read more
I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respiratory rate was 40+ and I couldn?t lower it), shaking uncontrollably (felt increasingly cold, though my temp was normal; my skin was cold to the touch but I felt like it was burning off), tachycardic (heart rate was 140bpm and I normally am at 60-80 at rest). My throat felt like it was closing and my face was swollen. I should have gone to the ER, but I wasn?t thinking clearly and didn?t know what to do with my small children. It took 2 hours until I stopped shaking, my heart rate returned to normal, and my breathing was under control. Since then I have mainly been fatigued, taking Tylenol for overall aches, and have not been able to tolerate much activity (can only stand for about 5 minutes at a time).
38 2021-01-09 weakness, vertigo, dizziness I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tens... Read more
I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tension and mid back muscle tension. Joint pains as well. These subsided after 48 hours except for the neck and upper back muscle fatigue and mild soreness. This gave me a low grade headaches almost daily since the vaccine. I took ibuprofen a few times which helped. On the 6th I awoke at night and felt weak all over. I felt like I was falling in my bed. Mild dizziness. I went to work and felt extremely fatigued with muscle weakness but no neuro deficits. I feared some terrible autoimmune illness and took Decadron that day- 4mg tab BID. This helped my muscle weakness but left me with insomnia. The decadron is now wearing off after 4 days and I still have muscle weakness/fatigue. It takes considerable effort walking up the stairs. Yesterday my masseter muscles became fatigued with little chewing. My arms feel heavy when I lift them. The strange thing is that at night when I lie down I feel like my sympathetic nervous system is being triggered. I will get palpitations and feel just strange- I can't describe it. I took valium to sleep last night -5 mg tablets that my doctor gave me Saturday as there seems to be an anxiety panic component going on. I have no history of diagnosed anxiety or panic attacks- I have never felt this way before. Today I feel a little better but still have considerable muscle fatigue and neck and upper back muscle soreness and overall muscle tightness in my arms and legs- feels good to stretch kind of feeling. I have mild dizziness when standing up and turning too abruptly. But no considerable focal neuro deficits.
38 2021-01-09 feeling cold, pain in extremity, tenderness, feeling hot, pain, weakness Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am ... Read more
Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am felt very tired, like I was about to catch a cold. 12pm felt cold, had a temp of 99.9 F 3pm was very tired, chills, mild nausea, temp 100.8 F - took tylenol at this point 1000mg. Tylenol helped reduced fever and chills. Still continued to feel very tired and had no energy. Stomach continued to feel sensitive and had very little appetite. 10pm - fever returned 100.6 with chills - took another dose of 1000mg tylenol and went to sleep. Through out the night was hot and cold. 1/8 7am - I woke up had temp of 100.1F - no chills, still very tired, arm still very sore. Did not take tylenol. 9am - temp now 99.7 F - still very tired 10am - temp now 98.6F - nausea resolved, still had no appetite. Very tired, body felt sore and left armpit hurt when I moved, I noted no lymph nodes. Remainder of day I remained fever free, but continued to feel very tired and took a few naps. (this is not my norm, I do not nap). By dinner time appetite was better but stomach still felt tender. 1/9 - woke up feeling great, lots of energy, even went for a jog. Arm still a little sore.
38 2021-01-09 pain in extremity, pain Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, di... Read more
Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, diarrhea, severe body aches, joint pain.
38 2021-01-09 pain in extremity Shot given in L deltoid. Day 3-10 post vaccine I had extreme pain in what seemed like my left trapez... Read more
Shot given in L deltoid. Day 3-10 post vaccine I had extreme pain in what seemed like my left trapezius muscles. The pain was much worse in the evening/night and was sometimes absent during the day. Also on day 14 post vaccine (1/7/2021) I developed a cold sore for the first time in my life.
38 2021-01-09 numbness The patient presented with left eye peripheral visual loss, left upper and lower extremity and facia... Read more
The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
38 2021-01-10 pain, pain in extremity, numbness (Saturday)rigors @about 730 PM with temp of 100.9. Tylenol 650mg taken. (Sunday)Body aches in th... Read more
(Saturday)rigors @about 730 PM with temp of 100.9. Tylenol 650mg taken. (Sunday)Body aches in the morning with temp of 100.5. Ibuprofen 600mg taken. Felt better about 3pm. (Monday) Pain/discomfort to armpit and numbness to Left arm (Arm that injection was given)
38 2021-01-10 dizziness 38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immed... Read more
38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling. Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine. The next day, patient again developed shortness of breath and her husband administered the EpiPen. EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on epinephrine drip. Stridor continued and was unresponsive to nebulized albuterol. Patient was then intubated and placed on mechanical ventilation. Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids. admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day. Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
38 2021-01-10 pain in extremity, pain 9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout th... Read more
9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout the night. Woke with a temp of 101.3 at 8am the next day, body aches, and headache. Fatigue and sweats until fever broke about 11am after more sleep. The afternoon decreased symptoms until only a mild headache and fatigue that night.
38 2021-01-10 tremor, restlessness, pain Awoke that night after receiving 2nd dose of Pfizer COVID-19 vaccine with fever, sweats/chills and b... Read more
Awoke that night after receiving 2nd dose of Pfizer COVID-19 vaccine with fever, sweats/chills and body aches. Experienced difficulty sleeping the rest of the night due to symptoms and restlessness. Following day, I continued to have fever averaging 100 degrees F, body aches, chills and headache that brought me to tears. That evening, began experiencing severe nausea and involuntary shaking. Reported to ER for management of symptoms. Received fluids, ibuprofen, Zofran and Reglan as well as potassium. It is currently the following Monday so 5 days post vaccine and I continue to have intermittent nausea and headache.
38 2021-01-10 tremor Beginning the evening after receiving vaccine 1/5/21 patient complains of nausea, headache. The ne... Read more
Beginning the evening after receiving vaccine 1/5/21 patient complains of nausea, headache. The next day the patient symptoms were chills, headache, restless legs, and a slight tremor. By Saturday 1/9/21, the patient was experiencing worsening restless legs, and tremors to the point she could the sleep or work. Patient reported symptoms to the pharmacy on monday 1/11/21, chills, nausea, and headache had subsided and tremors and restless legs were improving.
38 2021-01-10 pain Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5. Swollen ... Read more
Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5. Swollen left axillary lymph node noted. Sunday 1/10/2021 symptoms resolved except for lymph node enlargement and soreness at injection site. Taking tylenol and motrin with relief.
38 2021-01-10 dizziness C/O- Dizzy, light headed, states she had glasses of wine night prior, and massage this am before vac... Read more
C/O- Dizzy, light headed, states she had glasses of wine night prior, and massage this am before vaccination, cup coffee this am, no other food or liquid. Action- Monitored in OBS area, released after 30 minutes with no complaints
38 2021-01-10 dizziness Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 mi... Read more
Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 minutes of monitoring.
38 2021-01-10 dizziness Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work aft... Read more
Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work after 35 minutes of monitoring.
38 2021-01-10 dizziness, tingling Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain... Read more
Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain, even walking coughing makes brain hurt like tingling, loose stool, long bone pain, peri orbital edema, neck stiffness, new onset low back, loss of appetite, loss of taste, insomnia, fatigue and dizziness. I feel like I have all repeat symptoms of covid, with worse headache and neckstiffness than actual infection. Fever last for 3 days and disappeared but headache continues and ended up in ER. CTA negative, D dimer<200
38 2021-01-10 dizziness I received the vaccine in the late afternoon. I immediately Felt off. I was up most of the night wit... Read more
I received the vaccine in the late afternoon. I immediately Felt off. I was up most of the night with nausea and when I woke in the morning I was having both dizziness and Nausea. The nausea has subsided but I am still experience waves of dizziness.
38 2021-01-10 dizziness, tingling, feeling hot Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for severa... Read more
Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
38 2021-01-10 speech disorder Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing a... Read more
Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25 minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes. Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions, coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV Benadryl and IV Benadryl with marked improvement in symptoms.
38 2021-01-10 dizziness, feeling hot Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheel... Read more
Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheelchair. Patient symptoms improved briefly. Continuously monitored oxygen saturation and pulse. 3:12pm 110/60, P 78, O2 98% RA. 3:15pm call 911 to requested EMS due to patient reporting shortness of breath, throat tightening, chest tightness. 3:18pm 130/80, P 101, O2 99% RA, administered oral diphenhydramine 25mg and 0.5mg Epi (1:1000) via IM injection in right deltoid. 3:25pm 130/80, P 85, O2 93%. Ambulance arrives at 3:28 pm received report and transports patient via ambulance to Hospital.
38 2021-01-10 dizziness SCRATCHY THROAT , BLURRY VISION, LIGHTHEADEDNESS. SOLUMEDROL, BENADRLY, PEPCID. 1 LITER OF FLUIDS.
38 2021-01-10 pain in extremity, pain Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the ev... Read more
Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the evening - Aleve worked temporarily and then the side effects got worse, took another Aleve and eventually was able to sleep it off Arm aches at site of injection - still tender t otouch
38 2021-01-10 pain, pain in extremity That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just ... Read more
That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just did not feel right. As the day progressed I started having body aches, chills, extreme fatigue, still sore arm. I could not stand for long periods of time or I would start to fell like I was going fall right there in the floor.
38 2021-01-10 pain in extremity The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after ... Read more
The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after shot I started to feel extreme fatigue, muscle aches, slightly sore throat, mild congestion. I had a temperature of 99.1. I went to an urgent care and my BP was elevated (very unusual for me) 140/100 and HR 110 and temp still 99.1. They did a rapid swab on me that was negative. I continued to feel awful the rest of the day. On Sunday the next morning I awoke because I had a very swollen and sore lymph node in my left armpit. I took tylenol and did warm compresses. I had continued fatigue on Sunday and slept the whole day. I also continued with a high heart rate 110-130 with activity. My Bp was 117/70I had a pulse oximeter at home. My temp stayed 99. Monday morning I woke up feeling better. My HR was in the 80 and temp 98.3 and fatigue is gone. I still have mild soreness in my left arm but the redness is fine and warmth is gone. My left armpit is still sore
38 2021-01-10 dizziness chest tightness, trouble breathing, dizziness and blurry vision
38 2021-01-10 pain fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with im... Read more
fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with improvement of symptoms.
38 2021-01-10 numbness, feeling hot within minutes entire body numbness and "hot", followed by full body erythema. Was transported to th... Read more
within minutes entire body numbness and "hot", followed by full body erythema. Was transported to the ED for treatment.
38 2021-01-11 pain 12/18/2020 , 12/19/2020 felt sore and felt fine then Tues, middle of night with head ache and heart ... Read more
12/18/2020 , 12/19/2020 felt sore and felt fine then Tues, middle of night with head ache and heart rate high blood did not feel good took tyler and head ache chills and heart rate high blood and e k g tack cardi tylernol fever on/ slight fever and lots of water and second 01/08/2020 email the second dose taken fine. Fatigue and tylernol and sore 01/11/2020 headache, headache
38 2021-01-11 pain, tremor At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive hea... Read more
At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive headache and uncontrollable shaking and chills
38 2021-01-11 dizziness, feeling hot, lightheadedness Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness ... Read more
Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness and pain, tongue swelling, lip swelling, difficulty breathing, chest tightness, fast heartbeat, increased blood pressure. Given benadryl, epi, solu-medrol and pepcid. Kept for observation. After release, continuing to have intermittent hot flashes, itching all over face and body, occasional jaw tightness, sore throat and tongue, increase in pulse, O2 sats in low 90s,
38 2021-01-11 pain Body aches, chills, and sweats began 15 hours after receiving second dose of vaccine. These symptoms... Read more
Body aches, chills, and sweats began 15 hours after receiving second dose of vaccine. These symptoms lasted until 11:30 am. Alternating Tylenol and ibuprofen helped.
38 2021-01-11 pain, weakness, dizziness I awoke the next morning after my 2nd dose with the following side effects: Extremely light headed ... Read more
I awoke the next morning after my 2nd dose with the following side effects: Extremely light headed to the point it was hard for me to walk without feeling like I would pass out, body aches, severe headache, nauseous but never vomited, extremely tired as if I were given a sleep aid, and weak. I called my primary care physician to see if there was anything I could take to help, they advised me to take Ibuprofen and Tylenol. I started to feel better a few hours after taking Ibuprofen. The next day I just had a headache and am feeling tired. I would say the most extreme symptoms lasted about 10 hours and started to slowly feel better after that.
38 2021-01-11 pain I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive bliste... Read more
I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive blister on my mouth. I was in bed and couldn't take anyting.
38 2021-01-11 tingling, pain, speech disorder Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and w... Read more
Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Jaw/neck/throat area became tight like tensing up; Hard to talk, was shouting out one word at a time; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My fingers move often, like a compulsion; This is a spontaneous report from a contactable health care professional, the patient (patient). A 38-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscular in the left arm on 28Dec2020 19:00 as a single dose, for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital The patient had no known medical history or allergies. Concomitant medication included bupropion (BUPROPION), propranolol (PROPRANOLOL), sertraline (SERTRALINE), ethinylestradiol, levonorgestrel (PORTIA 21). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28DEC2020, the patient experienced Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion. Adverse event resulted in a physician office visit. No treatment was given for the event. The clinical outcome of Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion was not recovered.
38 2021-01-11 pain in extremity Left arm started hurting me the day after the vaccine and everyday the pain got worse it travel in t... Read more
Left arm started hurting me the day after the vaccine and everyday the pain got worse it travel in to my neck and back side of my upper back. On 01/12/2021 couldn't go to work due to the pain been higher and I couldn't turn my neck to the left side
38 2021-01-11 pain, pain in extremity Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side on... Read more
Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side only including neck and torso left side only X 4 days .
38 2021-01-11 numbness R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took... Read more
R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took 1/2 Benadryl after.
38 2021-01-11 pain in extremity, pain Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I f... Read more
Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I feel like I'm dying; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine), via an unspecified route of administration left arm on an unspecified date (unknown lot number and expiration date) at a single dose; and via an unspecified route of administration left arm on 04Jan2021 18:00 [06:00 PM] (lot number: Eh9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 17:00 [05:00 PM], the patient experienced severe fatigue, headache and body aches- feel like her skin is crawling and was hit by a freight train. The patient has never had a reaction like this before. The patient was also nauseous, and her arm is very sore, but she doesn't even notice since she feeling like she's dying. The patient has not been tested for COVID-19 since the vaccination. The treatment received by the patient for the adverse event included paracetamol (TYLENOL)/ibuprofen around the clock (OTC medication). The patient reported that the events was non-serious. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was not resolved. The following information on the batch/lot number has been requested.
38 2021-01-11 dizziness, feeling hot, pain in extremity, pain Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked lik... Read more
Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization. Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12). The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies. On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
38 2021-01-11 migraine, pain caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and mig... Read more
caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and migraines lasting 72 hours.
38 2021-01-11 pain pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable n... Read more
pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable nurse (patient herself). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 04Jan2021, at 0.3 mL, single for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications were not reported. Prior to taking vaccine, she did an antibody test and it was positive for antibodies s in Nov2020, she remembered that she went for a complete physical. All COVID tests were negative but the antibody test was positive. She did a rapid test a week before the vaccine at the end Dec2020. The PCR Test was a couple months before the vaccine in Apr2020 and it was negative. During that time in Apr2020 she had mild symptoms and was not feeling well but then she felt better. The doctor gave her azithromycin and vitamins, a week later she was better. At her job they were doing COVID test every 2 weeks, but she was negative. She had no more symptoms. She has had no issues with vaccines in the past. She would get unspecified flu shots at work for flu vaccination, but would get mild pain at the injection site. Patient received PFIZER-BIONTECH COVID-19 VACCINE on 04Jan2021 and had been experiencing pain at injection site, mild body aches, and mild headaches. Her 1st dose was on 04Jan2021 at 4 o clock. The pain at injection site began on 05Jan2021. The body aches and headache also started on 05Jan2021, but she noticed relief with Tylenol. She has called her physician since she does not want to go in office. Her symptoms were ordinary and mild but bothersome, she doesn't know with this vaccine and what she would be feeling and decided on staying home. The pain at injection site stopped sometime between yesterday and today. Her 2nd dose is scheduled on 25Jan2021. Outcome of the event pain at injection site was recovered on an unspecified date in Jan2021, while for the remaining events was recovering.
38 2021-01-11 pain severe body pain (headache, neck, lumbosacral, bilat arms, bilat calves, bilat legs. chills.
38 2021-01-12 pain 13 hours after vaccination developed severe arm tenderness at injection site, aches and chills. The... Read more
13 hours after vaccination developed severe arm tenderness at injection site, aches and chills. These lasted about 12 hours. Aches and exhaustion continued another 6 hours.
38 2021-01-12 tingling, dizziness @0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and ar... Read more
@0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and arms bilaterally. NAD, no SOB, v/s 154/110 (normal for her is 102/80s). 98% RA, hr 95, 96.9 temp and no pain. Did report dizziness. patient has a history of anaphylaxis. Evaluated her for 30 minutes after onset of symptoms. C/o anxiety and feeling seasick, never experienced respiratory distress at the end of her additional 30 minutes she reported feeling better.
38 2021-01-12 tremor, tingling, pain in extremity, pain Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took al... Read more
Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took aleve and a trazadone in hopes of getting some rest. I fell asleep. I woke up around 0200 on 1/13/21 with extreme muscle and joint aches, a sensation of pins, needles, and tingling all over my body I felt very jittery and was actually shaking slightly throughout the ordeal. I felt like my nervous system was overloaded and my perception of pain was extremely heightened. At one point during this 4 hour period I had a visual hallucination. By 0600 I was feeling better- more relaxed. Muscle aches and sore joints are still present today. Also have a slight increase in temp 99.6 and injection site pain.
38 2021-01-12 pain Body Aches, Fatigue, Injection site pain
38 2021-01-12 pain Body ache, chills, headache. Improving.
38 2021-01-12 pain Fatigue, body aches and chills
38 2021-01-12 pain Fever headache body aches nausea chest pain Tylenol
38 2021-01-12 pain Low-grade fever, chills, fatigue, body-aches, specifically aching neck,
38 2021-01-12 dizziness Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. ... Read more
Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. She was given water, Juice and laid down. After 30-40 minutes sxs subsided. Spoke to pt said she was Feeling much Better. Spoke to nurse at Rehab center. Pt reported she was Feeling much better By 5pm on 1-12-21.
38 2021-01-12 dizziness Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and ... Read more
Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and tongue tingling. Diphenhydramine 50 mg IM was administered at 1726. Patient progressed to swollen tongue and inability to swallow. Epinephrine 0.3 mg IM administered at 1800. Patient transported to ED. In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858. Patient symptoms resolved and she was discharged.
38 2021-01-12 pain, pain in extremity Soreness (Left Arm) x 2 days Fatigue (Intermittently) / 7 days Fever (Intermittently) / 7 days Body ... Read more
Soreness (Left Arm) x 2 days Fatigue (Intermittently) / 7 days Fever (Intermittently) / 7 days Body Ache/ 3days Chills /24 hrs.
38 2021-01-12 nerve pain, tingling, numbness Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subsi... Read more
Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subside after 30 minutes, but still lingering; symptoms lasted 1 day.
38 2021-01-12 numbness, tingling Systemic: Tingling/Numbness/Right side of face (injection given on right side); symptoms lasted 1 da... Read more
Systemic: Tingling/Numbness/Right side of face (injection given on right side); symptoms lasted 1 day
38 2021-01-12 pain Woke up to chills, then fever developed, up to 100.8. Fever/chills/body aches/headache lasted until ... Read more
Woke up to chills, then fever developed, up to 100.8. Fever/chills/body aches/headache lasted until the evening of 1/12. Felt miserable
38 2021-01-12 pain bad body aches, muscle pain, Headache, fatigue, still ongoing, had 2 negative tests for COVID since ... Read more
bad body aches, muscle pain, Headache, fatigue, still ongoing, had 2 negative tests for COVID since onset of symptoms
38 2021-01-12 weakness nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Feve... Read more
nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Fever highest so far at 101.6 , heart rate 132 at highest taken.
38 2021-01-12 dizziness reports feeling dizzy, walked over to EMS for eval and reported feeling anxious and better within 5 ... Read more
reports feeling dizzy, walked over to EMS for eval and reported feeling anxious and better within 5 minutes, sent home to husband waiting in car
38 2021-01-13 tenderness 1/11:motrin 800mg 1 hr prior to injection. minor pain at injection site. no redness or swelling no... Read more
1/11:motrin 800mg 1 hr prior to injection. minor pain at injection site. no redness or swelling noted. 1/12: still minor soreness at injection site but around bed time , I noticed pain in my armpit and swelling( fluid filled area) around possible lymph node. Palpable lymph node along left clavicle with similar fluid filled swelling. Took motrin throughout the day and 50 mg of benadryl at bedtime. 1/13: Left arm pit still swollen. more tender with movement. While at work i put hot compress in my arm pit to help with the pain and shortly after i noticed my left arm had bright red streaks from my arm pit to my wrist. It also was very mottled looking. My arm felt tight/heavy or kind of like a pinched nerve feeling.. I took motrin throughout the day for soreness and took benadryl at bedtime. I place ice pack under my arm during the evening as well. 1/14: Swelling remains in the armpit. Tenderness is getting better. Similar swelling around clavicle . Still taking motrin for inflammation and using ice pack under my arm.
38 2021-01-13 weakness, pain 1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injecti... Read more
1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injection site left arm. Temp 98.6 1/12: 0600am: Shaking chills, cold sweat, faint, nausea, headache, body pain, fatigue, skin sensitivity, pain injection site. 1/12: 0630am: Same as above, Temp 100.9, took Ibuprofen 3 tabs. 1/12: 0730am: Less of all symptoms, ate food. 1/12: 12:30pm: Headache, body aches and pains, weakness, fatigue, nausea, skin sensitivity, pain at injection site. 1/12: 1:12pm: Temp 99.5. took ibuprofen 3 tabs. 1/12: 2:15pm-3:40pm: Breakthrough body aches, pains, headache, skin sensitivity, pain at injection site. 1/12: 7:40pm: Body aches, tired. Temp 98.3. took Ibuprofen 3 tabs. 1/13: 0800: Slept well, no further pain medication, no further side effects except mild soreness at injection site. 1/24: 0800: no soreness to injection site.
38 2021-01-13 numbness Facial numbness, face turned red elevated BP
38 2021-01-13 pain Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen... Read more
Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen painful lymph node around collarbone on left side. Collarbone areas are visibly different due to swelling. Most symptoms resolved within 36 hours of second dose of Pfizer vaccine. However, swollen lymph node in left clavicle area has continued to get more painful and swollen. Will seek medical treatment if this does not resolve.
38 2021-01-13 pain Fever, chills, body aches, headache. Injection site is red and inflamed. It is also swollen and a... Read more
Fever, chills, body aches, headache. Injection site is red and inflamed. It is also swollen and a hard lump.
38 2021-01-13 pain Headache, body aches, fatigue
38 2021-01-13 pain Low grade fever, chills, body aches, headache
38 2021-01-13 feeling hot Patient presented for her second Pfizer vaccine January 11, 2021. She waited her 15 minutes and sta... Read more
Patient presented for her second Pfizer vaccine January 11, 2021. She waited her 15 minutes and started to pull away when she noticed that she was beginning to get warm. She looked in her car mirror and noticed a rash on her neck and chest. She then pulled back around to let us know of her reaction. Vital signs checked. BP was 122/68. HR was 97. Sp02 was 99% on RA. She denied any SOB. At 1657 she was given Benadryl 25 mg po that she swallowed without any difficulties. She reported that she began to feel better. Rash started to look better. Patient will wait another 15 minutes to make sure that her symptoms resolve. Patient is A0x4. She is talking without difficulty.
38 2021-01-13 pain Sever sore arm at injection site and to move arm, body aches, and fatigue.
38 2021-01-13 pain in extremity Soreness at the injection site, arm pain
38 2021-01-13 pain in extremity Soreness at the injection site, arm pain, headache and full body chills
38 2021-01-13 dizziness Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ... Read more
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to Hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at TCH. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
38 2021-01-13 feeling cold, dizziness Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ... Read more
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at hospital. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
38 2021-01-13 tingling Tingling (pins and needles) in bilateral hands, lasted approximately 24 hours, now improving but not... Read more
Tingling (pins and needles) in bilateral hands, lasted approximately 24 hours, now improving but not resolved No treatment yet
38 2021-01-13 feeling hot Within 10 minutes of receiving the vaccine, my heart began to race and I became very warm and sweaty... Read more
Within 10 minutes of receiving the vaccine, my heart began to race and I became very warm and sweaty. I was brought into another room for monitoring and my heart rate was above 100. After some breathing exercises, it came back down to the high 70s for a few minutes but then increased again into the 90s, at one point it was 113. My chest and throat then began to feel tight and I began sweating again. My face also felt funny on my right cheek. At that point I was first given 25 mg of benedryl then epinephrine. I was then taken to the emergency room via ambulance and was observed for approximately an hour. I was given an additional 25 mg of benedryl and discharged at 4:55pm. I was diagnosed with an allergic reaction and prescribed 25 mg of benedryl every 6 hours over the next 24 hours. The following morning, I experienced a hot flash with profuse sweating followed by chills. I was very tired and felt feverish throughout the day on 1/12 and stayed home from work. On 1/13 I still felt tired but was able to work. Today I feel mostly normal but still occasionally have had heart palpitations.
38 2021-01-13 pain sever body aches; head ache; nausea; Arm where vaccine was giving was swollen and red; Arm where vac... Read more
sever body aches; head ache; nausea; Arm where vaccine was giving was swollen and red; Arm where vaccine was giving was swollen and red; Arm where vaccine was giving was swollen and red and warm to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient (no pregnancy) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at site of right arm at 15:00 on 28Dec2020 at single dose for COVID-19 immunization. Medical history included eczema psoriasis, allergies: Augmentin, and birth control. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) for birth control within 2 weeks of vaccination and levocetirizine dihydrochloride (XYZAL). At 06:00 on 29Dec2020, the patient experienced sever body aches, headache and nausea. Arm where vaccine was giving was swollen and red and warm to the touch, body aches lasted for 24 hours, arm issue didn't not go away for 5 days. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of event arm where vaccine was giving was swollen and red and warm to the touch was recovered in Jan2021; of rest events was recovered at 06:00 on 30Dec2020.
38 2021-01-14 pain 2000 - neck pain, headache 2200 - mild body aches 0235 - severe chills, muscle/joint pain, headache.... Read more
2000 - neck pain, headache 2200 - mild body aches 0235 - severe chills, muscle/joint pain, headache. 0600 - fever 102.5F tympanic, took Tylenol 1000 mg + ice packs 0730 - temp 101.9 F; headache severe w/ nausea 0800 - took ibuprofen 600 mg; fatigue, took nap 0930 - temp 100.4 F 1400 - headache continues but much less severe; temp 99.0 F
38 2021-01-14 pain Fever at 103.1; Chills; Body aches; Fatigue; Headache; First dose administered on 19Dec2020; second ... Read more
Fever at 103.1; Chills; Body aches; Fatigue; Headache; First dose administered on 19Dec2020; second dose administered on 07Jan2021; This is a spontaneous report from a non-contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (12:00) (Lot number: EL0140; Expiration date was not reported), and then the second dose on 07Jan2021 (06:00) (Lot number: EK9231; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient's first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021 (06:00). On 07Jan2021 (23:00), the patient had fever at 103.1 (unit was not reported); chills; body aches; fatigue; and headache. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovering for 'fever at 103.1 (unit was not reported)', 'chills', 'body aches', 'fatigue' and 'headache'; and was unknown for 'first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
38 2021-01-14 pain Fever, chills, hives, body aches
38 2021-01-14 pain I woke up 12 hours after vaccination with fever, chills, and body aches. This lasted approximately 3... Read more
I woke up 12 hours after vaccination with fever, chills, and body aches. This lasted approximately 36 hours with extreme fatigue and sweating over the course of 2 days.
38 2021-01-14 migraine Migraine headache; This is a spontaneous report from a contactable nurse reporting for herself. A 38... Read more
Migraine headache; This is a spontaneous report from a contactable nurse reporting for herself. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular from 20Dec2020 11:00 in left arm to 20Dec2020 11:00 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included cetirizine hydrochloride (ZYRTEC). On 20Dec2020 17:00, the patient experienced migraine headache approximately 6hrs after injection. The patient recovered on unspecified date. No treatment was given to the patient for the event. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
38 2021-01-14 pain in extremity My entire arm is painful and there is now a knot under my left arm pit that is tender and there is r... Read more
My entire arm is painful and there is now a knot under my left arm pit that is tender and there is rash also under the same arm pit.
38 2021-01-14 dizziness, pain in extremity My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted... Read more
My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted like an extreme fatigue; palpitations; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 30Dec2020 at 38-years-old at a single dose for COVID-19 immunization. Medical history included blood clotting disorder from an unknown date and unknown if ongoing. The patient experienced the following events and outcomes: my heart rate, I was like in AFib (medically significant) on 31Dec2020 with outcome of recovering, very high fever of 103 (non-serious) on 31Dec2020 with outcome of unknown, dizzy, light headed (non-serious) on 31Dec2020 with outcome of unknown, arms sore (non-serious) on 31Dec2020 with outcome of unknown, exhausted like an extreme fatigue (non-serious) on 31Dec2020 with outcome of not recovered, palpitations (non-serious) on 31Dec2020 with outcome of not recovered. The clinical course was reported as follows: The patient stated, "the day after the shot I got a very high fever of 103. I was dizzy, lightheaded. My heart rate I was like in AFib, it was going from 60s to 50s all over the place. And this was the next day after the vaccination. That evening nothing my arms was just sore. But the next day all of these side effects just started in and even still today I just feel so exhausted like an extreme fatigue and I am still getting like palpitations." The patient stated, "So I went to urgent care and they check my vitals and stuff and when they wanted me to send me to the hospital. But I told them I will get a ride and I go by myself just because I didn't want, capable of an ambulance ride and I ended up just going home because I couldn't get a hold up anybody. So, I came home and took my blood thinner medication because I do have blood clotting disorder." In regard to the outcomes of the events, the patient stated, "I am not experiencing all of them still definitely my heart is much better. I am still getting palpitations but nothing near how it was that first day. I am experiencing extreme fatigue."
38 2021-01-14 migraine Nausea, racing heart, shakey, migraine, sore throat
38 2021-01-14 pain, tremor Racing hearr, shaking, body aches, head hurts so bad i cant walk, sore throat
38 2021-01-14 tremor, dizziness Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken... Read more
Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken Excedrin
38 2021-01-14 pain in extremity Sore arm and pain at injection site
38 2021-01-14 pain Took 2nd dose shot at approx 9am on 1/13/21. By approximately 5pm began to experience flu like symp... Read more
Took 2nd dose shot at approx 9am on 1/13/21. By approximately 5pm began to experience flu like symptom with no fever. Body aches, chills, jittery/insomnia. I took 4 doses of ibuprofen between 6pm on 1/13 and 6pm on 1/14. Effectiveness of ibuprofen was none to minimal. and symptoms fully returned within 3-4 hours. Symptoms lasted from 6pm on 1/13 until going to sleep at 10pm on 1/14. Woke up on 1/15 at 6am and all symptoms were resolved. I has no symptoms from 1st dose other than pain at the injection site for 24 hours.
38 2021-01-14 restlessness Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like sympt... Read more
Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like symptoms - no fever but had muscle aches, chills, jittery/restless/insomnia, fatigue - these symptoms continued until 10pm on 1/14. Took four doses of ibuprofen between 6pm on 1/13 through 6pm on 1/14. The ibuprofen was eith ineffective or slightly effective for a short period of time but all symptoms returned within 3-4 hours after taking ibuprofen. All symptoms resolved upon waking at 6am on 1/15/21.
38 2021-01-15 numbness, tingling, pain in extremity, pain Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in ... Read more
Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in the right hand. At 33 hours post injection developed a deep dull aching pain throughout entire right arm. This worsened, and after 2 more hours intermittent sharp shooting pain down the arm. Pain rated 6 out of 10 intermittently with a constant 3 out of 10 full ache. Difficulty falling asleep due to discomfort and at one point the pain woke me up from sleep. It was resolving by early the next morning, and disappeared by hour 48 post injection. These pains were not inclusive of the soreness and tenderness of the injection site or the muscle pain when lifting the arm. Those symptoms are still present to a minimal extent 54 hours after injection, at the time I am writing this report.
38 2021-01-15 pain Body aches day after injection. Headache every day for 6 days.
38 2021-01-15 numbness Chills, muscle aches, low grade fever 99.7, whole left arm numbness
38 2021-01-15 dizziness Fever 101 even after Tylenol and Advil Headache Chills Lightheaded Nausea Fatigue Foggy feeling
38 2021-01-15 pain in extremity Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was... Read more
Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was received. Entire upper arm where injection was received is sore all the way to elbow. Elbows and knees hurt like they were hyperextended. These symptoms started at 1000 am the day after the immunization.
38 2021-01-15 tingling sudden onset redness with rash to face and neck, generalized itching to upper body, skin tingling
38 2021-01-16 inability to speak Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle i... Read more
Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle in throat, and felt like tongue was swelling followed by hot flashes, ?cloudy? brain. My words didn?t want to form although I knew what I wanted to say. I was speaking very slowly. Heart rate was fast.
38 2021-01-16 pain Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, c... Read more
Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, chills, body aches, fever
38 2021-01-16 pain in extremity, pain Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These... Read more
Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These have caused me to not come to work for two days. I came back to work 1/16/21, still having headache, soreness on my left arm and feeling tired.
38 2021-01-16 weakness, tremor Fever, shaking chills >12 hours, drenching sweats, severe myalgias, headache, generalized weakness, ... Read more
Fever, shaking chills >12 hours, drenching sweats, severe myalgias, headache, generalized weakness, fatigue
38 2021-01-16 dizziness, weakness Shortness of breath, cough, dizziness, severe air hunger, weakness, fatigue,
38 2021-01-17 bell's palsy Vaccination on 1/6/2021. Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided... Read more
Vaccination on 1/6/2021. Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided facial weakness and asymmetry on 1/12/2021. Pt went to ED for evaluation. Pt diagnosed with Bell's Palsy and given Valacyclovir and prednisone to be taken orally for 7 days and referred to Neurology for ongoing care.
38 2021-01-18 tingling, dizziness, weakness, numbness Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to ... Read more
Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to history of food allergies/medication allergies/intolerances and is prescribed epinephrine. After 30 minutes no reaction was seen in return to work, as a healthcare, CMA. At 1500 hrs. became incredibly dizzy, flushed, hot sweats. Sat down with cool window open, facecloth. Legs became tingling and numb, blood pressure was taken at over 130/90, nausea increasing, could not keep eyes open due to dizziness and light, with headache developing. After 30 to 45 minutes of observation from healthcare staff/coworkers became incredibly weak in arms and legs, head became incredibly faint, nausea increased, headache, dizziness, extreme fatigue in regards to wanting to sleep. At which time clinical lead nurse/supervisor brought myself to emergency room department for further evaluation. Was brought into emergency room for further evaluation developed at this time a lump in throat feeling, and was given an IV of Benadryl 25mg and Pepcid 20mg with an hours of observation. Within an hour of observation extreme fatigue tingling numbness and dizziness head decreased. And was discharged from emergency room for vaccine reaction around 20:00. Home with Benadryl 25 mg and Pepcid 20 mg, 3 times daily to treat reaction. After reaction been dealing with headaches and nausea.
38 2021-01-19 tingling, feeling hot Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Diffic... Read more
Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Difficult to swallow water. Able to take Benadryl liquid within 5 minutes of reaction starting and drink water (4 bottles of 16 ounces). 15 minutes later felt returning to normal status. No epinephrine used.
38 2021-01-19 pain, dizziness Nausea , dizziness body aches
38 2021-01-19 pain, pain in extremity, tenderness Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hr... Read more
Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hrs later; Two days after vaccine tender to touch left elbow started hurting - later that day I could feel a hard rod-like structure in the elbow on that side > Two days after vaccine - whole arm was hurting. Developed Lymphadenopathy. Fourth day after vaccine: Auxiliary tail of Left breast was hard as well. Called my PCP - warm compresses and Ibuprofen. My arm - I still feel a hard vein in my left arm. The other symptoms went away after 6 or 7 days. (Although nausea stopped after two days.)
38 2021-01-19 dizziness Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the ... Read more
Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes; Dizziness;nausea;fever; This is a spontaneous report from a contactable nurse. This is the maternal report. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 11Jan2021 14:30 at a single dose on right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included prenatal vitamins. The patient experienced dizziness, nausea, and fever on 12Jan2021 10:00. Treatment was not received for the events. The outcome of the events dizziness, nausea, and fever was recovering. The mother reported she became pregnant while taking bnt162b2 (Pregnant at the time of vaccination?: Yes). The events were assessed as non-serious. The mother was 24 Weeks (gestational period) pregnant at the onset of the event. The mother was due to deliver on 03May2021. Last menstrual date: 24Jul2020. Patient did not receive any other vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
38 2021-01-19 numbness Starting 25-30 minutes after the first dose of the Pfizer-BioNTech Vaccine was administered, patien... Read more
Starting 25-30 minutes after the first dose of the Pfizer-BioNTech Vaccine was administered, patient started to experience numbness in her face, chest pressure and gastrointestinal discomfort.
38 2021-01-19 dizziness Systemic: Headache-Medium, Systemic: Dizziness accompanied by elevated blood pressure (175/111), blo... Read more
Systemic: Headache-Medium, Systemic: Dizziness accompanied by elevated blood pressure (175/111), blood pressure dropped within 10 minutes, most likely induced by anxiety-Severe
38 2021-01-19 numbness Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Sh... Read more
Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Shortly after that she noted some tingling in her throat. She was given diphenhydramine 50mg and monitored for roughly 1 hour total after her injection before having complete resolution of the tingling in her throat and marked improvement in facial numbness.
38 2021-01-19 pain, pain in extremity When I got up at 0530 yesterday (1/19) my right arm was so sore I couldn't lift it. I got to work at... Read more
When I got up at 0530 yesterday (1/19) my right arm was so sore I couldn't lift it. I got to work at 0700 and felt really drained and tired. I fell asleep without realizing it at some point and a coworker saw me and woke me up at 0930. I attended a lecture at 1000 and started feeling chills, aches, and was sweating. I tried to take notes but couldn't remember how to spell a lot of basic words and couldn't get my brain to focus. My boss sent me home at 1145. I was driving home and when I got off the interstate I couldn't remember which way to turn at the light off the exit. I had to pull up a navigation app on my phone to remember how to get home. When I got home I took my temperature and it was 98.5F. I slept for 3 hours, picked my kids up from school, and then slept for another 2 hours. I took my temperature at 1900 and it was 98.5F still. My chills and aches had lessened but not disappeared by the time I went to bed at 2100, but by the time my alarm went off at 0530 this morning I felt completely back to normal.
38 2021-01-19 pain Woke up at 7 am on the 19, Feeling extreme fatigue, body aches, low grade temp. I called the virtual... Read more
Woke up at 7 am on the 19, Feeling extreme fatigue, body aches, low grade temp. I called the virtual IU Health line to report symptoms. I spent all day in bed till symptoms started to subside which was around 4:30pm 01/19/2021. I was completely symptom free by 01/20/2021 at 0930 am.
38 2021-01-19 pain in extremity general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms... Read more
general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms resolved
38 2021-01-19 pain mild headaches, chills, body ache, severe fatigue, mild nausea. temp 99.7
38 2021-01-21 pain 12 hours after my first dose (1/19) I woke up with a high temperature, extreme body aches, sweating,... Read more
12 hours after my first dose (1/19) I woke up with a high temperature, extreme body aches, sweating, headache and nausea. These symptoms continued until the following morning (1/21) and then begin to subside. It's now 1/22 and the symptoms are coming back. I've taken Tylenol and ibuprofen, but I am still experiences headache, body aches, upset stomach and brain fog.
38 2021-01-21 dizziness About 9 am on 1-21-2021 started to ?feel off?, between this time and 11am I would get light headed ... Read more
About 9 am on 1-21-2021 started to ?feel off?, between this time and 11am I would get light headed at random. At 11am I started to see ?black floaters? and developed a slight headache. Coworker (another ICU RN) took blood pressure: 234/148 and tachycardia. Was made to rest while arrangements could be arranged and given 4 chewable baby aspirin. Was then sent to urgent care.
38 2021-01-21 pain Chills, headache, body aches , tiredness and stuff nose
38 2021-01-21 movement disorder I woke that day and felt off. Middle of the day, I got a sharp pain in my left upper back that went ... Read more
I woke that day and felt off. Middle of the day, I got a sharp pain in my left upper back that went up to my neck. I couldn't turn my head to the right. It kinda got better with some sleep. I did go in the next week and was seen.
38 2021-01-21 pain in extremity Muscle ache, fever, chills, nausea, fatigue, sore arm.
38 2021-01-21 pain in extremity Next day after of tired, fatigue, muscle ache, chills, arm ache, shortness of break and took a tyle... Read more
Next day after of tired, fatigue, muscle ache, chills, arm ache, shortness of break and took a tylenol. 01/13/2021 walk -in clinic and high heart rate and shortness of breath and fatigue. Covid -19 positive 12/04/2020
38 2021-01-24 dizziness Dizziness; Tachycardia; This is a spontaneous report from a contactable other HCP. This other HCP re... Read more
Dizziness; Tachycardia; This is a spontaneous report from a contactable other HCP. This other HCP reported for self that the 38-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID-19 Vaccine, Lot#: EL0140, Expiry Date: 31Mar2021), via an unspecified route of administration on 05Jan2021 13:15 on Deltoid, Right at single dose for covid-19 immunisation. Medical history included she did get a monthly allergy injection about 3-4 weeks prior to the COVID-19 Vaccine. She said she did not have any reaction to the allergy shot, clarifying she has always done well with her allergy shots. Concomitant medications were none. She said she got dizzy for about 30 minutes afterwards, and then was all better. Caller asked if Pfizer has any guidance on how she should proceed with the second COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported she got really dizzy approximately 10 minutes after receiving the COVID-19 Vaccine, and the dizziness lasted for about 30 minutes after that. She said the dizziness completely resolved. Reported she also got a little tachy (clarified as tachycardia) during the time period she was dizzy. She said she wasn't sure if she became tachycardic because she was worried when she became dizzy. She said the tachycardia resolved with the dizziness. No treatment was received. The events stared from 05Jan2021 and considered as Medically significant. The outcome of the events was recovered on 05Jan2021. Vaccination Facility Type was Hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE was require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant tests was none.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of dizziness and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-24 pain Pain in the body and headache, Fever, inflammation of the right axillary ganglion and chills. Sympto... Read more
Pain in the body and headache, Fever, inflammation of the right axillary ganglion and chills. Symptoms presented on 1/21/2021 and continued on 1/22/2021. Tylenol was taken continuously every four hours. On 1/23/2021 the symptoms were alleviated.
38 2021-01-25 seizure, tremor, pain in extremity AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVER... Read more
AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVERE ARM, NECK, AND CHEST PAIN. SHORTNESS OF BREATH THAT IMPROVED OVER TIME. ON 1/23/21 COMPLAINED OF SEVERE ITCHING OVER ENTIRE BODY
38 2021-01-25 pain On the afternoon of 1/23/21, I began having achiness and fatigue, which lasted through 1/26/21. Head... Read more
On the afternoon of 1/23/21, I began having achiness and fatigue, which lasted through 1/26/21. Headache, nausea, and fever ranging from 99.1-100.9 also experienced with onset on 1/24/21 through 1/25/21.
38 2021-01-25 pain, tremor fever, body aches, neurological tremors to leg
38 2021-01-25 dizziness really big sharp headache; lots of vowel movements (Diarrhea); Chills; dizziness; This is a spontane... Read more
really big sharp headache; lots of vowel movements (Diarrhea); Chills; dizziness; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (right arm, second dose) from 12Jan2021 17:00 to 12Jan2021 17:00 at a single dose for COVID-19 vaccination. Medical history included UTI. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 (first dose). It was reported by the patient that she was awaken in the middle of the night because of a really big sharp headache also with lots of bowel movements (Diarrhea). The patient also had Chills and dizziness; all on 13Jan2021. There was no treatment for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
38 2021-01-25 swollen extremities this was maybe an allergic reaction; itching; her face was red; her arm, it was really red; her arm,... Read more
this was maybe an allergic reaction; itching; her face was red; her arm, it was really red; her arm, it was really puffy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at deltoid left on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), biotin and multivitamin. On an unspecified date, the patient reported that she has a lot of itching going on, people were saying her face was red, she felt itchy, it was as if she could write her name on her arm, it was really red and puffy, her left eye stated to itch, but she did not want to scratch, she thought this was maybe an allergic reaction, her pathologist gave her two ZYRTEC, she was supposed to take one, and took another one as well. Course of event was reported as follows: the patient clarified that itching started during night, her scalp started itching a little, then stomach, then she was like ok. The next, she finished working out, got a shower, she did shower and continued to itch. At work, all of a sudden, her arms started itching, then legs started, then stomach and back started itching, her coworker said it was red, face was red. It was not intolerable, but uncomfortable. The patient outcome of the events was unknown.
38 2021-01-26 dizziness Dizziness and lightheadedness. Given juice and crackers; had not eaten since breakfast. Also given ... Read more
Dizziness and lightheadedness. Given juice and crackers; had not eaten since breakfast. Also given water. Symptoms resolved. Monitored for 30 minutes.
38 2021-01-26 pain, migraine Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non... Read more
Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non-productive cough (on day 2). treated with Tylenol, IBU, and routine migraine medication, hydration.
38 2021-01-26 migraine Headache/migraine, lasted 12-15 hours, took ibuprofen
38 2021-01-26 migraine Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the ... Read more
Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
38 2021-01-26 numbness, feeling hot Patient reported feeling of warmth in chest 10 minutes after vaccine administration. She then repor... Read more
Patient reported feeling of warmth in chest 10 minutes after vaccine administration. She then reported warm sensation and numbness in bilateral hands ~20 minutes after vaccine administration. All symptoms above resolved within 40 minutes after vaccine administration. She remained well appearing throughout observation period and had no evidence of airway compromise, facial swelling or vomiting during 40 minute observation period. Her vitals remained stable throughout: BP 97/61, HR 68 BP 107/70, HR 60
38 2021-01-26 pain, dizziness, lightheadedness Shot recieved Wednesday. By Wednesday night, I had a headache (forehead and back of neck) and fatig... Read more
Shot recieved Wednesday. By Wednesday night, I had a headache (forehead and back of neck) and fatigue. Friday I became dizzy, and had 2 near fainting spells (this included dizziness, weak muscles, and slight loss of sight). I became achy (back and shoulders) and my headache continued. These dizzy spells and headaches have continued for 6 days. The dizziness is starting to subside, however the headache and fatigue remains.
38 2021-01-26 pain in extremity Soreness in left arm with a knot/lump where injection was given.
38 2021-01-26 tingling Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip t... Read more
Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip tingling. Patient was administered diphenhydramine PO while in clinic. At this time, patient declined to be seen in the ED and was released from clinic after additional monitoring. Patient received a course of prednisone from another physician later that day. 2 days later the patient began experiencing severe abdominal pain and was seen in the ED. Labs, right upper quadrant ultrasound, and abdominal CT were within normal limits and was determined that symptoms were likely still part of COVID vaccine anaphylactic reaction. The patient was evaluated by the acute care surgery service who did not find anything concerning and was discharged home from the ED with return precautions and instructions to follow-up with primary physician. The patient follow-up with PCP and was continued on a 5 day course of steroids. The patient will not receive a second vaccine dose at this time and was referred to see an allergist for further testing.
38 2021-01-26 dizziness hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a s... Read more
hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021, she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-26 pain intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contacta... Read more
intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contactable physician. A 38-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at left arm on 06Jan2021 14:00 at single dose for COVID-19 immunization. Patient had Covid prior vaccination. There were no concomitant medications. No other medications in two weeks. No other vaccine in four weeks. On 07Jan2021, The patient experienced fever and body ache for the first 2 days. On the 3rd day (19Jan2021) experienced intense chest pain and nasal congestion. she needed to go to Emergency Room where she stayed for 4 hours, and performed Thorax CT. No treatment received. The outcome of events was recovering.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-26 dizziness severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous rep... Read more
severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous report from a contactable Other HCP (patient). A 38-year-old female (pregnant: No) patient received 1st dose of BNT162B2 (COVID vaccine, lot number= EK9231) on 11Jan2021 12:30 PM on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient experienced severe dizziness, disorientation, unable to finish any tasks. Tired, some muscle aches, L ear pain and chills (no fever) on 11Jan2021 01:00 PM. No treatment. Outcome of the event was Recovered/Resolved with Sequel. No further information is expected. Information on the Batch/Lot number has been obtained.
38 2021-01-27 inability to speak, numbness, migraine Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Pati... Read more
Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Patient presented to Emergency Dept. Sxs resolved in one hour.
38 2021-01-27 numbness, tingling head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contacta... Read more
head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.
38 2021-01-28 tremor Anxiety, flushing, EPs-tremors 12:30 increasing. MD on site assessing. Pharmacist administered epi p... Read more
Anxiety, flushing, EPs-tremors 12:30 increasing. MD on site assessing. Pharmacist administered epi pen at 12:40. 911 called. Left facility at 12:45
38 2021-01-28 pain Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This... Read more
Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This is a spontaneous report from a contactable other healthcare professional (patient). This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3249) via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunisation. Relevant medical history included penicillin allergy and allergy to clindamycin and doxycycline. Concomitant medications were not reported. The patient had a nasal swab COVID test result positive on 01Jan2021 after the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) administered on 21Dec2020 in the left arm for COVID-19 immunization. On 11Jan2021 at 21:00, the patient experienced temperature, chills, body aches, headaches, nausea, vomiting, diarrhea, fatigue and stomach pains. The patient underwent a Nasal Swab on 11Jan2021 which was positive. The patient did not receive corrective treatments. The patient had not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030273 same reporter/patient, different dose of COVID-19 vaccine/event
38 2021-01-28 pain, pain in extremity The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first ... Read more
The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first round of the vaccine she only had a super mild sore arm and a slight headache.; sore; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on 28Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included ongoing pernicious anaemia, a b12 deficiency. She gives herself B12 shots. She was diagnosed 2-3 years ago. She also had a Myomectomy, 15 cm uterine fibroid , removed this past summer. Concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) for pernicious anemia. The first round of the vaccine she only had a super mild sore arm and a slight headache. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks. She has been working from home. She has not been exposed to people. She keeps feeling like she needs to stretch because she is sore. The patient underwent lab tests and procedures which included COVID 19 test on an unspecified date: negative, COVID-19 antibody test on an Unspecified date, Result: negative. The outcome of the events was unknown.
38 2021-01-28 feeling hot, involuntary muscle movements, pain, pain in extremity nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivit... Read more
nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivity to light; eyeballs felt sore; cold sweats; when she talked, she felt like she had to close her eyes because of pressure; arm was hurting really bad; received the 2nd vaccine yesterday/ date of the first vaccine was 28Dec2020; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 14Jan2021 15:30 to 14Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included ongoing pernicious anaemia, a B12 deficiency diagnosed 2-3 years ago (she gave herself B12 shots and she cannot convert B12 through her food), and myomectomy (15 cm uterine fibroid, removed this past summer). Concomitant medication included ongoing cyanocobalamin (B12) for pernicious anemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 28Dec2020 at a single dose for COVID-19 immunization; and a flu shot (the MA gave it in the back of her arm, it was pretty significant). The patient was a nurse and informed that she received the second COVID vaccine the day before report (14Jan2021). She woke up on the day of report on 15Jan2021 03:00 with a nasty headache, she felt hot, had the creepy crawly shivers, was achy and when she talked, she felt like she had to close her eyes because of pressure, and she was nauseous. She figured this was probably normal but she couldn't get a hold of her doctor and the hospital she worked at did not know what to tell her. She was wondering if she can take Tylenol or ibuprofen and has even thought about drinking caffeine, that it might help her headache. She didn't have a prescribing doctor as she got it at work. The first round of the vaccine she only had a super mild sore arm and a slight headache. She received the second vaccine at 3:30pm and then went to bed when she got home. She woke herself up at 3 am because her arm was hurting really bad. She started feeling like she couldn't keep her legs still. She felt hot, achy, and was shivering. She hasn't taken her temperature. When she woke up at 3 am she got on her phone, and her eyesight felt like she couldn't quite focus. It wasn't bad, but she felt like she was straining. Then her head started hurting at 5-7 am. She was very sensitive to light. She woke up and couldn't go back to sleep. She had cold sweats, and was shivering. Every time she stood up, she was chattering. She felt achy almost like growing pains. She woke up with the arm pain, and then 10-15 minutes later, she started feeling that creepy crawly feeling. She got up and the cool fan hit her, and she realized how bad she was shivering. The shivering intensified at times but hasn't gotten worse. She had just called employee health and realized that when her eyes were open when she was talking was when she felt nauseated. She has noticed the nausea in the past half hour. She did not know if it was related to the headache or what. She had to cover her eyes, her eyeballs felt sore. When she talked with her eyes open, she felt a little queasy. She was just straining to see. Her vision was not blurry but she can tell she was straining. She did not know if it was because of the headache and nausea. When she got out of bed, the cold fan did not feel cold but it made her shiver. She was a nurse was trying to be socially responsible as she did not want to get COVID. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks and had been working from home. She has not been exposed to people. She kept feeling like she needed to stretch because she was sore. The patient was tested for COVID pre-surgery (myomectomy) and was negative. She was also tested for COVID antibodies and she did not have any. She was vaccinated at a hospital facility. Patient received no other vaccines on that day. The adverse events did not require any visit to the emergency room or physician office. Patient did not receive prior vaccines in the previous 4 weeks. Outcome of the events cold sweat and "tested for COVID antibodies and she did not have any" was unknown, nasty headache was reported as worsened (not recovered), and the remaining events was not recovered. The reporter considered the events serious due to medically significant events and related to the suspect drug.; Sender's Comments: Based on the information currently available, a possible contributory role of BNT162B2 vaccine in the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-28 pain the vaccine was administered too far up and may have been given subcutaneously; developed a lump and... Read more
the vaccine was administered too far up and may have been given subcutaneously; developed a lump and redness in the injection site; developed a lump and redness in the injection site; Pain; This is a spontaneous report from a contactable nurse reporting for herself. A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), subcutaneous on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified medications (patient take medications). She received on Wednesday (on 13Jan2021) the second dose of the Covid vaccine and she developed a lump and redness in the injection site. In her opinion the vaccine was administered too far up and may have been given subcutaneously, the patient did not know if the injection was too far up while getting on the muscle. She would like to know if this was a side effect of the medication. The patient also experienced pain on 13Jan2021. The patient tried taking Tylenol for pain and took a dose of Motrin for pain, but that was it, the nurse assessed causal relationship between pain and COVID Vaccine was Yes. The outcome of the events was unknown.
38 2021-01-31 pain, pain in extremity, dizziness, feeling hot Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations,... Read more
Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
38 2021-01-31 migraine, pain Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, ... Read more
Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, extreme fatigue, slept for 28 hours at one time, no appetite, runny nose, fever, chills,.
38 2021-02-03 tremor, numbness Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and... Read more
Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-20 facial paralysis I had a major stroke on 12/25/2020, 9 days after receiving the vaccine. I had a clot in my MCA. My ... Read more
I had a major stroke on 12/25/2020, 9 days after receiving the vaccine. I had a clot in my MCA. My left arm was completely flaccid, with left facial droop and garbled speech. Thankfully I was able to receive TPA that day, which resolved all of my symotoms.
38 2021-02-21 weakness 2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness,... Read more
2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM
38 2021-02-21 pain Chills, fatigue, hallucinations, shortness of breath, chest pain, and body aches
38 2021-02-21 feeling hot, numbness Pt complained of extremity feeling warm internally, itching, and numbness.
38 2021-02-22 pain in extremity, pain On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really ... Read more
On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really read, red hard rash, my face turned very red, pain on my shoulder & neck, and very bad headaches, my work send me o the emergency room, & also I had hard time seeing everything was very hard to see. I felt very nauseas I couldn't eat for the first couple of days, a lot of body aches & felt very fatigue. In the emergency room they prescribed me Trimodal & Zofran. I had to miss 4 days of work it lasted about 7 days the first 4 days my symptoms were sever but by the 5th day it was getting better.
38 2021-02-22 tingling On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and ... Read more
On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and third day after the vaccination the patient started to feel joint pain, tingling sensation.
38 2021-02-22 pain in extremity Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, head... Read more
Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, headaches, chills, diarrhea. All recovered other than the sore eye.
38 2021-02-22 pain in extremity, pain The day they gave me the vaccine I had a lot of pain in my left arm, I felt my arm very tired, if I ... Read more
The day they gave me the vaccine I had a lot of pain in my left arm, I felt my arm very tired, if I grabbed something I could not hold it for a long time, the next day , on Thursday I had the same pain but it was also a pain in the armpit and it went to my left breast, along with a prick, on Friday I continued having pain in my armpit, like I was sore and I noticed that my neck hurt a lot, only on that side, I called my doctor and she told me to take ibuprofen and if I still having problems to go to the emergency room, by late in the night I felt a small ball near to my neck and when I touched it hurt a lot, to this day nothing hurts but the small ball still there, it doesn't hurts when I touch it nothing., I had palpitations but
38 2021-02-23 tingling Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to E... Read more
Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to ER for further treatment.
38 2021-02-28 feeling of body temperature change, pain Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetit... Read more
Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.
38 2021-03-02 pain Severe body aches and headaches 12 hours after administration of 2nd dose.; Severe body aches and he... Read more
Severe body aches and headaches 12 hours after administration of 2nd dose.; Severe body aches and headaches 12 hours after administration of 2nd dose.; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262, expiry date: not reported), via an unspecified route of administration at left arm on 30Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included polycystic ovary syndrome (PCOS), gilbert's syndrome, bipolar disorder, and allergies to sulfa. The patient received unspecified concomitant medication received within 2 weeks of vaccination. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), at left arm on 13Jan2021 at 06:30 PM for COVID-19 Immunisation. On 31Jan2021 at 04:30 AM, the patient experienced severe body aches and headaches 12 hours after administration of 2nd dose. The reporter considered the events non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The outcome of the events severe body aches and headaches was unknown. No follow-up attempts are possible. No further information is expected.
38 2021-03-09 dizziness, tremor, speech disorder, balance disorder symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; s... Read more
symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; This is a spontaneous report from a contactable Other HCP. A 38-year-old non-pregnant female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 (Lot number: EL3302) via intramuscular route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included environmental allergies, Type 2 diabetes mellitus, Mixed hyperlipidemia, Attention deficit hyperactivity disorder, Obesity and Anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium at 20mg, Desogestrel/Ethinylestradiol (Azurette) at (23) 0.15mg-0.02mg (21)/0.07mg (S), clotrimazole and betamethasone at 1%-5%, cyclobenzaprine at 10mg, escitalopram oxalate (lexapro) at 20mg, metformin at 500mg, esomeprazole magnesium (nexium) at 20mg, montelukast sodium (singulair) at 10mg, amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (Adderall) at 20 mg, cetirizine hydrochloride (zyrtec) at 10 mg, fluticasone proplonate at 50mcg. It was unknown if the patient had illnesses at the time of vaccination and up to one month prior. Patient was seen in office on 27Jan2021 and reported symptoms of Headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors causing change in handwriting for the past 1.5 to 2 weeks after receiving vaccination. Upon review of Neurological symptom, patient was positive for loss of balance and coordination 4/5 strength. In all extremities, and 4/5 grip strength, CT of Head with and W/O contrast was ordered. CBC, CMP, free T4, HgbA1c, lipid, 'TSH, Urinalysis, Vitamin B12, Folate and CK laboratory ordered. CT Head with and w/o Contrast on 27Jan2021 showed no acute intracranial process Identified. No evidence of enhancing lesion. Patient had not completed laboratory at this time. It was unknown if the patient had doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
38 2021-03-18 pain Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fe... Read more
Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fever; Body Aches; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 26Feb2021 at a single dose (at the age of 38-years-old) for Covid-19 immunisation in a workplace clinic. Medical history included allergies, migraines, low vitamin D and penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrum and doxycycline and experienced allergies. The patient was not pregnant at time of vaccination. The patient took the first dose of BNT162B2 on 05Feb2021 10:30 in the left arm at the age of 38-years-old for Covid-19 immunisation. No other vaccine was received in four weeks. The patient did not have COVID prior to vaccination. On 27Feb2021 at 02:30 AM, the patient experienced headache, chills, fever, body aches and an episode of syncope which caused a fall. The events resulted in emergency room/department or urgent care. The patient had a CatScan, EKG, IV medications, blood and urine test. The patient was not tested for COVID post vaccination. The patient recovered from the events on an unspecified date.
38 2021-03-20 feeling hot blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the admini... Read more
blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the administration spot; then I vomited; excessive heat coming out of my body like hot flash; fell on my face; like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat; This is a spontaneous report from a contactable consumer, the patient. A 38-years-old (also reported as 45 years old) non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, in the right arm on 01Mar2021 at 13:30 (at the age of 38-years-old) as a single dose, for covid-19 immunization. The facility in which the vaccine was given was Doctor's office/urgent care The patient had no known medical history or allergies. Concomitant medication were reported as yes but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02Mar2021 04:00, the patient experienced blackout/ I wasn't able to see him only hear his voice (medically significant), panicking sensation, , mild pain in the administration spot, vomited, like excessive heat coming out of my body like hot flash, fell on my face, when my husband touched me it became worse I'm talking about the heat. The reporter explained on mild pain in the administration spot, but after I went to bed I woke up to use the restroom and suddenly I had blackout and fell on my face It was panicking sensation my husband rushed for help he was talking to me but I wasn't able to see him only hear his voice then I vomited and there was like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat and my eyes were widely open in a scary way. Body temperature was checked with a thermometer and it was 98.1. The patient went back to bed was feeling the same blackout sensation. Consumer stated she is a healthy person in all means and never had such thing before. The patient underwent lab tests and procedures which included body temperature: 98.1 on Mar2021. No treatment was given for the events. The clinical outcome of the events Blackout, Vaccination site pain, fell on face, panicking sensation, vomited, hot flash and Feeling hot was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
38 2021-03-22 weakness 103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a con... Read more
103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a contactable Nurse. A 38-year-old female patient (no pregnant) received 2nd dose of BNT162B2 (lot number=ENS318) Intramuscular on 03Mar2021 10:00 AM on Left arm for COVID-19 immunisation. Medical history was Fibromyalgia, allergic to insect stings and fleas. No other vaccine in four weeks. Other medications in two weeks included venlafaxine hydrochloride (EFFEXOR), gabapentin, cefixime (FLEXERIL), and hydrocodone bitartrate/paracetamol (NORCO). Historical Vaccine was 1st does of BNT162B2 (lot number=ENS 318) Intramuscular on 10Feb2021 11:00 AM on Left arm for COVID-19 immunisation. Patient experienced 103 .5 fever, dehydration, muscle aches, vomiting and weakness from 03Mar2021 06:00 PM with outcome was recovering. Events resulted in Emergency room/department or urgent care, Hospitalization (1 day). Treatment included IV fluids, Tylenol, Zofran. Drew labs which were normal. No covid prior vaccination. Covid test post vaccination: Nasal Swab Negative on 04Mar2021, PCR Result Pending. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported fever, dehydration, muscle aches, vomiting and weakness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-03-29 pain, pain in extremity Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a sponta... Read more
Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) on 23Feb2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriatic arthritis and hidradenitis suppurativa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included spironolactone (ALDACTONE) and women's multivitamin from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 23Feb2021 at 23:30 the patient experienced "same as generally expected," arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
39 2020-12-31 weakness Severe Headache for 3 days, chills weakness and fevrerish
39 2021-01-01 weakness Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diapho... Read more
Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diaphoresis, neuropathic crawling all over scalp, loss of consciousness, heart rate 35 bradycardia event. Responders said I was out for a minute or so then regained consciousness. Pupil dilation during event per responders. ICU MD responder states no radial pulse but had carotid pulse which was weak at initial loss of consciousness. Given fluids. Blood pressure normal during fluids. Improved heart rate without tachycardia. Had recurrence of clammy hands, globus sensation with frequent swallowing/throat clearing about 30 minutes after initial event while still receiving fluids. No airway compromise or stridor. Received PO Benadryl 25 mg. Transferred to ER for monitoring for an additional 90 minutes with complete resolution of globus sensation about 30 minutes after Benadryl. Fatigue and weak post event.
39 2021-01-01 dizziness Within 45 min, patient had nausea, dizziness, and was given ondansetron and fluids with improvement
39 2021-01-02 difficulty speaking, pain in extremity 23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice... Read more
23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice; 24th: sore arm, headache, fatigue, congestion; 25th: headache, nausea, fatigue, congestion. 26th through today - daily Headache w/nausea (OTC's not helping headaches).
39 2021-01-02 numbness Face became numb 25 minutes after vaccine administered. Relief came the next morning 12/22/2020, 07... Read more
Face became numb 25 minutes after vaccine administered. Relief came the next morning 12/22/2020, 0700.
39 2021-01-03 dizziness 12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tendern... Read more
12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tenderness in injection site. No adverse effects until 2 pm (dizziness, headache, fatigue, nausea, chills). Got home by 5pm. Worsened symptoms. Temperature hit 40C. Myalgias and joint pain started. Took Tylenol 1gm. Recurrent fever and chills. Symptoms did not get better. 12/30/20 started having pressure and stabbing chest pain. Went to ED for dehydration and nausea. Negative chest xray and troponin. COVID PCR also negative. As of 1/4/2021, writer is still experiencing same symptoms to a lesser extent.
39 2021-01-03 pain 2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dr... Read more
2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation. The evening after injection I had a headache and just felt general malaise and fatigue, "run down". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help. I slept better that night but woke up with night sweats, completely drenched. Arm pain at injection site on day 2 that resolved by mid day. Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.
39 2021-01-03 pain, weakness Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder an... Read more
Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder and neck muscle pain. She got in touch with her provider and was treated with valium and Celebrex. She reported about 2 cm swelling and fatigue. Thirty hours post vaccination, she had pain and swelling and could barely move. Dr. needed to take valium and Celebrex though for those 48 hours, and would have gone to the ER if they had not helped (the pain was that debilitating)
39 2021-01-03 tingling Erythema, swelling, warm to touch, around injection site. "tingling down arm to metacarpals per pat... Read more
Erythema, swelling, warm to touch, around injection site. "tingling down arm to metacarpals per patient"
39 2021-01-03 dizziness I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75b... Read more
I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75bpm), and lightheadedness. I sat down and had a few sips of water. Within a few minutes, I felt like I was having a difficult time getting a good breath in. I raised my hands over my head and took slow deep breaths to try and keep my breathing under control. I stayed at the hospital for about 45 minutes, over which time I had a few bites to eat and some water. The flushing and sweating resolved within that time. The lightheadedness and "feeling of doom" lasted about 3 hours. I had no anxiety going into this vaccine, nor have I had a reaction like this before.
39 2021-01-03 tingling, numbness I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingli... Read more
I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingling in my right jaw/mandible area that spread behind my ear. Over about an hour or 2 I could feel the numbness/tingling/strange sensation move across the top of my right lip and into my right nostril. I took benadryl and it seemed to stop the spreading but the strange sensation stayed on the right side of my face for about 4 days afterwards.
39 2021-01-03 dizziness I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30. By 17:00 I was not feeling well. I ... Read more
I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30. By 17:00 I was not feeling well. I was tired, had a headache, muscle aches, nausea and a fever of 101 F. The headache, low grade fever and significant malaise continued through Tues Dec 22 and Wed Dec 23. On Thursday morning Dec 24 at 2:30 AM, I woke from sleep with the urge to use the bathroom. I suddenly felt light-headed and dizzy and had a diaphoresis that soaked my hair and PJs. Fortunately my husband who is a nurse anesthetist helped me through the episode safely and was able to get me back to bed. I am not sure if that event was related to the vaccine or if I happened to be a little dehydrated and had a vaso-vagal event. I did not take any medications because I was allowing my body to have a natural response to the vaccine.
39 2021-01-03 numbness Reported lump in her throat and coolness of left arm which was treated with Benadryl 25 mg po; HR=84... Read more
Reported lump in her throat and coolness of left arm which was treated with Benadryl 25 mg po; HR=84 and BP=128/88; then had severe cramping in right leg with foot numbness; patient transported to the Emergency Department
39 2021-01-03 pain Severe anterior right shoulder pain associated with very limited ROM due to pain. No pain at injecti... Read more
Severe anterior right shoulder pain associated with very limited ROM due to pain. No pain at injection site. No swelling or erythema at injection site. Pain is in anterior shoulder and radiates down right arm. Pain is constant but worse with movement. Pain started the night that vaccine was given 1/2/2021 and has been persistent since then making it difficult to work. Pain not relieved with tylenol or ibuprofen. Pain is more severe that what would be expected from needle trauma. Of note, vaccine was given particularly high near subdeltoid bursa.
39 2021-01-03 tingling Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Sever... Read more
Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Severe cramping in hands and feet; Severe bone pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EL0140, via an unspecified route of administration in left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to PCN, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of report. Concomitant medication included omeprazole (PROTONIX), ibuprofen (MOTRIN). No other vaccines were administered in four weeks. On 19Dec2020 at 14:30, the patient experienced fever 102.9 "normal for vaccines i know", tingling in lower legs neuropathy like, severe cramping in hands and feet, and severe bone pain. The patient recovered from the events in Dec2020. The patient did not receive treatment for the events. The events were reported as non-serious. The patient didn't have COVID prior to vaccination and was not tested post vaccination.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of neuropathy like cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-03 pain in extremity arm pain
39 2021-01-03 pain in extremity, numbness injection was administered into left joint and not intramuscular. symptoms included nerve intrapme... Read more
injection was administered into left joint and not intramuscular. symptoms included nerve intrapment for 3 days with severe pain in the left arm, extending into the wrist. muscles weakness, numbness into the thumb , index and middle finger. Inability to raise arm. pain persists today
39 2021-01-03 pain in extremity, numbness noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and ... Read more
noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and shoulder girdle, diagnosed with parsonage turner syndrome by neurologist, currently taking neurontin for pain as steroids not tolerated
39 2021-01-04 nerve pain 48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles... Read more
48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles 1 year ago - same type pain but this time head to toe, comes and goes but consistent).
39 2021-01-04 pain, dizziness Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcu... Read more
Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcutaneous but I did end up with an injection site reaction 2 days later to include a 2x3 inch red, itchy, raised, hot to the touch welt. Also had extreme dizziness, nausea, headache 2 days after injection. Dizziness, nausea, headache subsided after 24hrs however injection site reaction will go away and come back randomly. Seems to coincide with getting sick? Was fine up until 12/29 when I did end up getting sick to include headache, body aches, chills. I went to go get covid tested which was negative. I ultimately had a sinus/ear infection. However injection site reaction had gone away UNTIL I got sick on 12/29 then it showed up again and still have it as of today.
39 2021-01-04 dizziness Dizziness, headache
39 2021-01-04 pain Employee was feeling fatigued on Mon, 1/4. By Tuesday afternoon while at work, she was experiencing ... Read more
Employee was feeling fatigued on Mon, 1/4. By Tuesday afternoon while at work, she was experiencing body aches and "felt my heart racing." She was sent to the ER by her supervisor and her SBP was 180s and HR was 120s. Employee does not have a hx of HTN or heart conditions.
39 2021-01-04 pain in extremity Fever of 100.2, chills, fatigue, sore arm
39 2021-01-04 pain Fever, chills, nausea, headache, body aches
39 2021-01-04 numbness I began experiencing tachycardia and numbness in my hands and feet.
39 2021-01-04 pain, pain in extremity I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate ... Read more
I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate tiredness and body aches and headaches that were really bad until the 23rd that was sporadic. I felt feverish malaise really bad headache and body aches. I took Tylenol and Advil around the clock. on the 20th I also had very mild runny nose for 2 days. I went to get a covid test on the 23rd and it was negative. Symptoms resolved by the 25th I had no symptoms
39 2021-01-04 pain PT was verbalizing prior hesitancy to vaccine once received @ 10:58 - 3 minuets post injection PT C/... Read more
PT was verbalizing prior hesitancy to vaccine once received @ 10:58 - 3 minuets post injection PT C/O neck/ throat feeling tight, sis increased to C/O feeling like heart was racing, feeling diaphoretic and shaky. EMS called to car for assessment BP- 156/106 pulse - 110 follow pulse - 76 BP- 132/87. PT up and standing to help case symptoms PT had also C/O L side pain after dose administered, 11:30 patient states she starts to feel ok, then she no longer feels "normal" C/O heaviness in head/ neck.
39 2021-01-04 tingling Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started fe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started feeling tired with some chills. By 1700, I was having nausea and vomiting. I woke the next day (1/3) around 0700 still having nausea, but also my hands and feet were very cold and my arms and legs were cold and clammy. This continued throughout the day. It is now 1/5 and I'm still having some nausea and my extremities are still cold and will sometimes tingle.
39 2021-01-04 pain, tenderness about 1 week after first shot, develop hard lumps on clavicle (same side as shot given). site very ... Read more
about 1 week after first shot, develop hard lumps on clavicle (same side as shot given). site very painful and tender. determined to be swollen lymph nodes caused by vaccine.. Currently lumps have decreased in size and no pain.
39 2021-01-04 numbness burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had ho... Read more
burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination. The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
39 2021-01-04 tremor developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous... Read more
developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous and kind of shaking; Allergic reaction; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), intramuscular in the left arm on 24Dec2020 at 08:00 AM in the hospital at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination, has no known allergies, had no other medications in two weeks, and did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. At 3:00 PM of 24Dec2020, the patient developed a severe tachycardia with no other symptoms. She walked herself to the ER (Emergency room/department or urgent care), was nervous and kind of shaking. By the time they got to her, her heart rate was stable and was at 88. Transient tachycardia was at around 120-140 for 7 minutes and resolved with no intervention. Basic labs came back normal. She got discharged from the ER. The patient didn't think they reported it but she was willing to cooperate in any way. The patient was not treated for the adverse events. As per the patient, she reported her adverse reaction (after the 1st dose) on the website as recommended. She experienced "very fast heart beat 8 hours after receiving the vaccine". The patient was inquiring if she would be contacted after. The patient also asked if the very fast heartbeat was related to the vaccine because the reaction did not happen right away like usual, she was not sure if it was an allergic reaction since it happened 8 hours later. Outcome of the event 'Tachycardia' was recovered in Dec2020, while for the other events was unknown. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
39 2021-01-04 dizziness, feeling cold feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 1... Read more
feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.
39 2021-01-04 tingling, numbness in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm... Read more
in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm where she received the shot, her hand and wrist go numb with pins and needles; her arm is sore; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (left arm) on 20Dec2020 06:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other vaccine administered on same date of the Pfizer vaccine. The patient reported that she had the vaccine on Sunday (20Dec2020) and had a side effect that she didn't see listed. She stated that in the arm where she received the shot, her hand and wrist go numb with pins and needles, it was getting progressively less. She added that her arm is sore, but she expected that. She further stated that last night it just happened one time and it feels a lot better now. The patient asked if those were an expected side effect. The patent clarified that she received the COVID 19 vaccine on 20Dec2020 0600 in the left arm. On 21Dec2020 in the night at 0200 she woke up with pins and needles in her hand and wrist. It happened only when she was asleep and not moving her arm. She added that actually she feels it very faint off and on in the day but each night it has improved. She further clarified that the pins and needles are in her lower arm and wrist radiating up the arm. She added that she will be scheduled for the second dose. The outcome of event vaccination site pain was unknown, while the outcome of other events was recovering.
39 2021-01-05 weakness, feeling hot 10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness... Read more
10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness, and shortness of breath. I sat down, my heart rate was 110 on my I watch. I was breathing heavy and feeling sweaty. The healthcare providers had me lie down on a stretcher and gave me oxygen with my feet elevated. After about 20 minutes, I felt better. Later that day, I came home and slept for 2 hours. The next day, (today) I came home early from work because I feel very tired and having difficulty concentrating. But the other symptoms have gone away.
39 2021-01-05 dizziness 15 to 30 minutes after vaccination experienced itchy throat and tongue and dizziness
39 2021-01-05 inability to speak Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, hea... Read more
Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, headache, dropping things.
39 2021-01-05 tingling, numbness Associate began to c/o hand numbness to left arm with fingers tingling. 1135: 183/98 BP, HR 68, Oxy... Read more
Associate began to c/o hand numbness to left arm with fingers tingling. 1135: 183/98 BP, HR 68, Oxygen 100% on room air. 1140: BP 179/111, HR 79, oxygen 100% 1145: BP 160/104. HR 72. Oxygen 100. Associate states numbness has resolved and to followup with her PCP about elevated BP and numbness.
39 2021-01-05 pain in extremity, dizziness Dizziness, NauseaVomiting, Arm soreness
39 2021-01-05 weakness, dizziness blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular ... Read more
blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT). The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "blood pressure went up to 150/101" with BNT162b2 can not fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-01-05 pain in extremity extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left ar... Read more
extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
39 2021-01-05 pain temp 99.5, fatigue, body aches, headache
39 2021-01-06 weakness (1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the ... Read more
(1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the rest of the day. (1/6/21) It was my day off, I was still weak and headache I took Tylenol for the pain. (1/7/21) About 3:00 am I had a lot of headache I got up and took 2 Tylenols,the pain continued but more bearable I went to work at 6am always with a headache and feeling weak. From work they sent me home so that I could take the Covid Test, and also do this report.
39 2021-01-06 migraine 1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week... Read more
1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week after vaccine horrible migraines.
39 2021-01-06 dizziness About 1 hour after receiving the vaccine she began to feel dizzy, felt like she was going to pass ou... Read more
About 1 hour after receiving the vaccine she began to feel dizzy, felt like she was going to pass out, racing heart and pupils became constricted.
39 2021-01-06 dizziness, tremor Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and m... Read more
Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and my throat felt numb and a little swollen. I was still able to swallow and symptoms did improve after 15 minutes.
39 2021-01-06 pain, dizziness At approximately 3am (11 hrs after vaccine), had chills, body aches, severe headache, dizziness. Ch... Read more
At approximately 3am (11 hrs after vaccine), had chills, body aches, severe headache, dizziness. Chills lasted about 4-5 hours, body aches x 24 hrs, and headache 24 hrs.
39 2021-01-06 pain Back pain, body pain, headache, stuffy nouse. Went to do covid test and came positive
39 2021-01-06 pain Body aches, chills, fatigue
39 2021-01-06 weakness, dizziness Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11... Read more
Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11am) but is subsiding, but continues. Pfizer's information sheet said this may be a sign of an allergic reaction. No medical follow up seems necessary right now, but important to report.
39 2021-01-06 dizziness Dizziness, severe headache, abdominal pain, diarrhea, nausea, fatigue, and muscle pain
39 2021-01-06 numbness Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye sw... Read more
Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye swelling and tongue swelling. Then felt like throat closing up within 7 minutes of receiving vaccine. Received vaccine in the clinic, was transported to Emergency Room. In ER received Epinephrine, steroids, Benadryl and Pepcid.
39 2021-01-06 pain Moderate to severe itching at all prior scar sites, some decades old. Severe itching/discomfort sur... Read more
Moderate to severe itching at all prior scar sites, some decades old. Severe itching/discomfort surrounding Nexplanon implant. Previously broken/fractured bones, and site of 20 year old rotator cuff tear, all throb with dull pain as if they are new injuries. General feeling of malaise, lack of appetite, and mental fogginess. All symptoms continue to persist still 48 hours after vaccination. Also experienced fever of approx. 102 degrees for roughly 24 hours.
39 2021-01-06 numbness, tingling Right sided facial numbness and tingling
39 2021-01-06 dizziness Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF... Read more
Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF, Zofran inj.
39 2021-01-06 pain, weakness Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibupr... Read more
Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibuprofen, was having body aches and severe chills. Went back to bed and took my temp an hour later was 101.0. Had body aches, chills, thirst, weakness, headache for the rest of the day. Temperature went from 99.0 to the highest of 102.0. Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs. If not then I would need to get covid tested. Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done. It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
39 2021-01-06 migraine, pain site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturban... Read more
site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturbance night of injection, elevated temp of 100deg (started at 0200 on the 6th and lasted for 24 hours), whole body aches esp neck and back pain (Started when temp started and has lasted after temp has stopped for a total of 31 hours). Migraine with sensitivity to light (started at 0400 on the 6th and lasted for 5 hours). Nausea and heartburn (started on the 6th at 1845 lasting 5 hours despite taking famotidine)
39 2021-01-07 dizziness 1000- Employee receives vaccination 1015- Pt reports dizziness to staff 1015- Pt assisted to priva... Read more
1000- Employee receives vaccination 1015- Pt reports dizziness to staff 1015- Pt assisted to private area for evaluation/assessment (Vitals signs, ABCs) - Denies troubles breathing or swallowing, Denies throat swelling or closure. drinking PO liquids and eats cracker 10:21- reports sensation in throat, continues to deny troubles breathing or swallowing 10:28- 25mg liquid PO diphenhydramine administered PO as 25mg/10mL PO diphenhydramine 10:31- No improvement/worsening in symptoms- emergency response team called to evaluate employee Pt is transported to Urgent Care via wheelchair per Pt request
39 2021-01-07 dizziness 1000- Pt received vaccine (2nd dose) 1015- Pt reported dizziness, denies troubles breathing or swal... Read more
1000- Pt received vaccine (2nd dose) 1015- Pt reported dizziness, denies troubles breathing or swallowing Pt assisted to private area- Vital signs checked and assessed for airway, breathing, circulation concerns- denies 1021- Pt reports unusual sensation in throat, continues to deny difficulties breathing or swallowing 10:28- 25mg diphenhydramine administered PO as 25mg/10mL PO Liquid diphenhydramine (Pt declines additional 25mg dosing) Denies changes in symptoms- emergency response team is called and arrives to assess Pt Pt is transported to Urgent Care per Pt request
39 2021-01-07 pain At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck ... Read more
At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck (no discomfort or itching). At the 12-hour mark I developed severe chills and body aches and exhaustion which came on very quickly. At (approx.) the 13-hour mark my temperature was 103.3 but it never got any higher than that. For the next 24 hours my temperature hovered around 101-102.
39 2021-01-07 numbness Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongu... Read more
Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongue went numb; Residual ringing in left ear; This is a spontaneous report from a contactable physician, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included seasonal allergies and allergies/asthma, from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020 at 16:00, the patient experienced elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear. The patient was treated for the events with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear was resolved with sequel. Information on lot/batch number has been requested.
39 2021-01-07 tingling Employee received COVID vaccine on 1/6/2020 and developed bilateral hip pain that night and then dev... Read more
Employee received COVID vaccine on 1/6/2020 and developed bilateral hip pain that night and then developed numbness and tingling in her buttocks and both legs on 1/7/2020. Employee was sent into Emergency Room.
39 2021-01-07 dizziness Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfi... Read more
Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfizer vaccine was given at 11:45 AM and reaction onset at 11:55. VS at 12:10: BP 132/67; HR: 100; O2 96%; Epi given at 12:22; Was taken to ED for observation. Patient has PMHx of RA and Asthma; Meds include Methotrexate, Advair, Omeprazole, Vit D; Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.
39 2021-01-07 swollen extremities, numbness, tingling Numbness and tingling on whole left side of body from head to toes on side vaccine was administered.... Read more
Numbness and tingling on whole left side of body from head to toes on side vaccine was administered. Swelling to left arm/hand.
39 2021-01-07 facial paralysis, numbness Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and the... Read more
Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and then left. She states on her way home she started feeling that her tongue and left side of her face was a little bit numb. It continues to be numb and on examination the left side of her face has diminished sensation. Her left eye is droopy and she has a symmetrical eyebrow raises as well as smile. Her diagnosis is consistent with possible Bell's palsy.
39 2021-01-07 pain Rash following first dose Second dose: rash, fatigue, body aches, fever
39 2021-01-07 feeling hot UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left a... Read more
UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left and called staff and reported hives on upper and lower lips, lips warm to touch Narrative: Reported lip numbness c/ injection, reported to monitor no action taken. Employee left after 15mins. Employee reported hives on upper and lower lips, lips warm to touch ( text message) no action taken
39 2021-01-07 pain in extremity, numbness Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain ... Read more
Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain in right arm starting in shoulder and runs down the entire arm. Pain continues 1 week after receiving the injection. Mild swelling continues in right shoulder. Having numbness in right hand.
39 2021-01-07 dizziness Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had mu... Read more
Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had multiple vagal episodes before, including with other vaccines, I oncreased my SVR by kneeling down. Symptoms resolved after 15min of continuous kneeling.
39 2021-01-07 pain chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and ax... Read more
chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and axillary lymph node soreness
39 2021-01-07 tingling extremities were still cold with occasional tingling; hands and feet were very cold and arms and leg... Read more
extremities were still cold with occasional tingling; hands and feet were very cold and arms and legs were cold and clammy; hands and feet were very cold and arms and legs were cold and clammy; feeling tired with some chills; feeling tired with some chills; nausea; vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 02Jan2021 08:00 at single dose at left arm for covid-19 immunization. Medical history included arthritis, hip replacement, calcified DVT. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D, gummies). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took acetylsalicylic acid (ASPRIN) and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient received the first dose on 02Jan2021 at 08: 00. At 14: 30, patient started feeling tired with some chills. By 0500 (as reported), patient was having nausea with vomiting. The next morning on 03Jan2021, patient woke at 07:00, patient still had nausea, but also, hands and feet were very cold and arms and legs were cold and clammy. It was 05Jan2021 now and patient still had nausea and extremities were still cold with occasional tingling. Patient didn't receive treatment for events. The report is considered non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events nausea and extremities were still cold with occasional tingling was not recovered, and outcome of other events was recovering.
39 2021-01-08 dizziness About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I... Read more
About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I tried to read my email and the words were there but didn't have meaning. I had to drive home after my 15 minute observation and plugged my home address into my gps so I wouldn't get lost even though I drove home from Medical Center for years. I got home and laid down and slept for a couple hours and woke up fine. I felt ok the following day and was doing laundry around 6 pm and my arm stopped being sore and I got really dizzy and nauseated and my vision had shadows (reminded me of an ocular migraine) and drank 2 x 16 oz glasses of water and laid down and felt better in about 20-30 minutes.
39 2021-01-08 pain in extremity, pain I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and bod... Read more
I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and body aches. I have also noticed my neck hurting and this am I notice a knot like form on my left clavicle bone that was not there prior to the the vaccine. I have not had any treatment for this.
39 2021-01-08 dizziness, pain in extremity No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet pa... Read more
No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet painful pins and needle sensation.
39 2021-01-08 pain On 1/8/2021 I woke up with severe chest pain under my breast bone, radiating to my upper back. It ca... Read more
On 1/8/2021 I woke up with severe chest pain under my breast bone, radiating to my upper back. It came in waves a severe sharp pain and then was dull. I?ve never had heartburn or indigestion so I went to Urgent care around 10am on 1/8/2021.
39 2021-01-08 feeling hot One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of... Read more
One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of delivery: August 22, 2021
39 2021-01-08 weakness, speech disorder Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 ... Read more
Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 1/6/21 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Pt had televisit consult with psychiatry and neurology. She is subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. She is noted to have a history of shellfish allergy. She experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time.
39 2021-01-08 dizziness Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 mi... Read more
Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 minutes after dose #2 of vaccination. No hx of adverse vaccine response. Only seasonal allergies. High-risk pregnancy at 25 weeks. Hx of feeling dizzy when she gets up suddenly, otherwise, no other medical issues. V/S taken over 45 minutes with noted decrease in BPs which was not normal for her. Apple juice x3 given at increments of 15 minutes and finished 1 bottle of water. Reports feeling better and then s/s returned. States she feels tired during episodes and back to normal. Advised to be evaluated in ED since her drive was more than 55 minutes away from hospital. Agreeable and was transported to ED for observation. B/P: 9:51 110/58, 10:09 92/58, 10:25 91/49 HR: 9:49 63, 9:59 80, 10:09 80, 10:25 80 SpO2: 9:49 99, 09:59 99, 10:09 99, 10:25 97 No other interventions given. Wheeled to the ED, room 505 at 10:41. Report given to RN.
39 2021-01-08 numbness, tingling numbness and tingling in left side of face (1/8), also in tongue and right hand (1/9)
39 2021-01-08 lightheadedness tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening... Read more
tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening face rash and itching. Following day flu like symptoms as well as sore throat and congestion.
39 2021-01-09 pain 1/5/21 started with fever (up to 101), severe body aches, shaking from being cold even bundled with ... Read more
1/5/21 started with fever (up to 101), severe body aches, shaking from being cold even bundled with electric blanket, nausea and vomiting. That lasted through 1/8. On 1/7 I started having trouble with taking a deep breath. Chest would get very tight and hurt when I would take a big breath, bend forward, or lay back. I went to express care and they could not rule out pericarditis. Told me to go to the Emergency Room for further work up to rule out spontaneous PE or pericarditis.
39 2021-01-09 balance disorder, dizziness 15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I st... Read more
15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I started to sway), and my throat felt thick like something was stuck in it. Staff sat me into a recliner and called an ICU attending. Benedryl IM was given. Throat symptoms did not get worse but did take about 10-12 hours to resolve.
39 2021-01-09 vertigo Day 2 Friday: Headache, Chills, Vertigo, severe Nausea & Vomiting; Treatment: Esgic for Headache, Zo... Read more
Day 2 Friday: Headache, Chills, Vertigo, severe Nausea & Vomiting; Treatment: Esgic for Headache, Zofran for N&V Day 3 Saturday: Headache, Fever 101.1, Severe N&V; Same treatment Day 4 Sunday: Moderate N&V with mild headache, no fever, Treatment: Zofran
39 2021-01-09 pain in extremity Fever 101.4 Arm sore
39 2021-01-09 weakness Fever, chills, weakness, fatigue, headache
39 2021-01-09 pain Headache, fatigue, body ache, malaise
39 2021-01-09 tingling, lightheadedness Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands las... Read more
Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands lasted for 2 hrs Following day- chills and abd cramping Day 3 -headache
39 2021-01-09 dizziness My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and in... Read more
My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and included the following: -Intense dizziness that was also electric like and lasted 36 hours -Severe headache lasted 36 hours and mild for 48 hours -Fever last was intermittent for 48 hours. I only started recording it 24 hours after the vaccine was administered. My max temp was 101. -Nausea (1 episode of vomiting) lasted 36 hours -Muscle aches and joint pain lasted 36 hours -Extreme fatigue lasted 48 hours -Injection site pain and swelling are still present, but are now mild -Enlarged lymph node in armpit of the same arm that vaccine was administered. This was discovered about 24 hours after receiving the vaccine and is still present. It?s about 1 inch in diameter.
39 2021-01-09 feeling hot, dizziness Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snac... Read more
Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snacks. BP 121/83, HR 98. Resolved after observation. Husband picked up her.
39 2021-01-09 pain Severe Headache, body aches, chills, fatigue, and metallic taste in mouth
39 2021-01-09 tenderness Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and ... Read more
Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and tenderserness day 3-4, just over
39 2021-01-09 dizziness dizziness moderate x 45 minutes and currently mild
39 2021-01-10 pain, dizziness 1/8/21 Recieved vaccine. 1/9/21 started feeling dizzy, lightheaded, tired, body aches, right arm ly... Read more
1/8/21 Recieved vaccine. 1/9/21 started feeling dizzy, lightheaded, tired, body aches, right arm lymph nodes are swollen and tender. 1/11/21 flank pain and upper back pain woke her up today. 1/11/21 made appointment to be evaluated by provider.
39 2021-01-10 dizziness 10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours la... Read more
10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.
39 2021-01-10 pain About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared... Read more
About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared on both arms from shoulder to elbow, I had moderate pain in all joints of both legs, and severe fatigue came on suddenly. I had to go to bed. The next morning, I had a headache, all joints felt mildly aches, moderate fatigue, and the splotchy rash remained on both arms still from shoulder to elbow. I took ibuprofen and rested in bed most of the day.
39 2021-01-10 pain in extremity Arm soreness Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue Took advil (400 mg) 1/9/21 @ ... Read more
Arm soreness Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue Took advil (400 mg) 1/9/21 @ 2 am and another 400 mg on 1/9/21 at 5:30 pm. Sxs did not recur since 1/10/21
39 2021-01-10 pain Body aches & severe joint pain, from shoulders down to toes, headache & neck pain, sore throat.
39 2021-01-10 tingling Developed a tingling sensation on the left side of her body and face after getting the first vaccine... Read more
Developed a tingling sensation on the left side of her body and face after getting the first vaccine. She had no weakness and was able to go about her normal day to day activities. The sensation went away with Tylenol and resolved the following day.
39 2021-01-10 feeling cold FEVER, CHILLS
39 2021-01-10 pain GI upset , headache, chills, left side of body hurts
39 2021-01-10 feeling cold, pain I had a slight headache while at work but was fine. I was home and was a little cold and my throat w... Read more
I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply. I checked my BPM and it was 80-82 and normally its about low 70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
39 2021-01-10 pain I had an expected immune response, low grade fever, headache and body aches, all the resolved within... Read more
I had an expected immune response, low grade fever, headache and body aches, all the resolved within 10 hours. I only feel the need to report them as they coincided with my first injection rather than my second injection. I am curious if that is because I had COVID 19 in 4/2020 and therefore my immune system was already primed to respond. If it turns out to be a pattern, I think it would be helpful for others who have already had the disease to be given a heads up before their first injection. Thanks for all the work you do!
39 2021-01-10 pain I received my vaccine at 8:40 am on 1/6/20. By that evening I noticed I was having decreased urine o... Read more
I received my vaccine at 8:40 am on 1/6/20. By that evening I noticed I was having decreased urine output. Starting Thursday morning I had very minimal urine output for18 hours. I also had flank pain. During this time I also had a fever, body aches, etc. I am an ED nurse and knew to hydrate myself. I hydrated all day and evening. Thursday night I had no urine output for 6+ hours. Starting Friday morning I had minimal urine output and it was brown tinged. As the day progressed my output increased slowly and changed from brown to pink/orange. I continued to hydrate drastically. Saturday morning my urine was pale yellow and clear and my pain was gone. I believe I had an acute kidney injury. Fortunately I knew to drastically hydrate and maintain that.
39 2021-01-10 dizziness, numbness My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affe... Read more
My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affected the right side of face and throat.
39 2021-01-10 pain in extremity, pain Nausea, body aches, fever chills, left arm pain, left axilla pin with adenopathy. Fatigue. Headache... Read more
Nausea, body aches, fever chills, left arm pain, left axilla pin with adenopathy. Fatigue. Headache.
39 2021-01-10 dizziness Post first dose of pfizer covid vaccine I had 2-3 days of intermittent headaches starting approximat... Read more
Post first dose of pfizer covid vaccine I had 2-3 days of intermittent headaches starting approximately 4 hours after dose and also 4-5 days of intermittent lightheadedness. I developed redness at injection site 4 days post dose and it is still present as of today even though it seems to be fading. Site is still painful to the touch.
39 2021-01-10 pain Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was va... Read more
Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was vaccinated at 0710, waited my 15 minutes drove home ( 15 min) showered and then just before 9 am realized Inwas itchy. Checked chest area and had red blotches similar in pattern to an anaphylactic reaction I had a few years earlier to betadine exposure. The night of the vaccine Inwoke up with nasal congestion and rhinorhea, itchy ears and throat, watery eyes. This became worse throughout the following day where I continued benadryl 50mg q6 as well as alternating tylenol and ibuprofen for body aches
39 2021-01-10 pain, numbness, tingling Within an hour of the injection patient broke out in hives followed by numbness and tingling on the ... Read more
Within an hour of the injection patient broke out in hives followed by numbness and tingling on the left side of the face. Mild headache with body soreness started approximately 8 hours after injection and lasted for about 12 hours. Benadryl was taken to relieve the hives, Advil and Tylenol were alternated to relieve headache and body soreness. The numbness of the face was resolved about 12 hours after onset.
39 2021-01-10 pain in extremity developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract... Read more
developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-10 pain in extremity fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, t... Read more
fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, took Tylenol and brought fever down to 101.7. Next day, woke up to sunburn rash on face, trunk to groin and legs, fatigue lasting all day. Next day 1/9, rash was still there, fever reached 100 lasting all day and fatigue.
39 2021-01-10 pain r sided neck pain and stiffness worse with motion
39 2021-01-11 dizziness Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection. Headache, ch... Read more
Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection. Headache, chills, Nausea, dizziness and fatigue for 2 days. January 10 is second covid vaccine date and January 12th woke up with a swollen left Armpit close to the breast. Left axillary lymph node swollen ? Not sure until I see a doctor. Will go to ER or Immediate Care to get it checked out.
39 2021-01-11 pain in extremity, pain Arm soreness Fever Malaise Chills Body aches
39 2021-01-11 feeling hot Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness.... Read more
Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness. Able to respond to verbal commands.
39 2021-01-11 numbness Cold, clammy, fast HR rate of 143, just didn't feel well could find words to describe it and shaky. ... Read more
Cold, clammy, fast HR rate of 143, just didn't feel well could find words to describe it and shaky. Left hand numbness opposite site of injection site. Set to ED to be evaluated
39 2021-01-11 tremor Fever 100.8 after Tylenol for 10-24 hours post vaccination. , extreme chills, shaking, waking from s... Read more
Fever 100.8 after Tylenol for 10-24 hours post vaccination. , extreme chills, shaking, waking from sleep. Severe fatigue, unable to work for 2 days post vaccination. Unable to do daily activities. 24 hours after vaccination fever resolved, temp elevated 99.5-99.8, fatigue is mild to moderate.
39 2021-01-11 dizziness Flushing dizziness and nausea
39 2021-01-11 pain in extremity Headache, nausea, left arm pain
39 2021-01-11 pain in extremity Mild sore arm
39 2021-01-11 pain in extremity, pain Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a conta... Read more
Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231/expiration date Apr2021), dose number 1, via an unspecified route of administration on 04Jan2021 14:30 at a single dose on the left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient previously had a flu shot for immunization and experienced fever, body aches, jumpiness, and arm hurting. She had no concomitant medications. She did not have any vaccination within 4 weeks prior the administration of the suspect vaccine. The patient was reporting side effects with the Pfizer vaccine. The events started in the morning of 05Jan2021 with the feeling of nausea. She also experienced jumpiness. In the evening, she had body aches, chills, and arm hurting. She also had fever, but it was not a very high fever. She took Tylenol on 05Jan2021 and on 06Jan2021, she had no body aches or fever yet. She felt much better on 06Jan2021. Her second dose is scheduled on the 25Jan2021. The patient received the vaccine at a workplace clinic. The outcome of the event was recovering.
39 2021-01-11 dizziness Patient developed throat tightening. Lightheaded, not feeling well. Administered diphenhydramine 5... Read more
Patient developed throat tightening. Lightheaded, not feeling well. Administered diphenhydramine 50 mg po once.
39 2021-01-11 dizziness Pt had immediate dizziness, followed by fever of 101 the next day, followed by intermittent dizzines... Read more
Pt had immediate dizziness, followed by fever of 101 the next day, followed by intermittent dizzinesss since, which it now has been about a week, as well as nausea.
39 2021-01-11 tingling Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the ... Read more
Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the afternoon it spread to her left jaw, neck, face and lips. She proceeded to be seen by UC. She took tylenol. She improved. She had nausea and seats as well. This is similar to the symptoms she had of covid the month previous.
39 2021-01-11 pain Received the vaccine and the following day started experiencing aches, chills, nausea and headache. ... Read more
Received the vaccine and the following day started experiencing aches, chills, nausea and headache. An ERT (emergency response was called at work) ; however, there was no further treatment.
39 2021-01-11 pain, tremor Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, ki... Read more
Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, kidney area pain. Fatigue following. Missed work the following day.
39 2021-01-11 pain Symptoms ? EE woke up at 01:00 with body aches, chills and HA. EE reports she went back to bed and ... Read more
Symptoms ? EE woke up at 01:00 with body aches, chills and HA. EE reports she went back to bed and when she woke up around 07:00 EE reports swelling and tenderness in L axilla region. EE reports complete resolution of body aches, chills and HA approximately 36 hours after vaccine. EE reports she continued with swelling and tenderness to L axilla region through today (1/12). Last day of work and shift - ? working today Home remedies? - rest and Tylenol (last dose Sunday 1/10 in the morning) Any improvement? ? improvement with time per EE Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.
39 2021-01-11 pain in extremity The day after I had a sore arm, fatigue, headache.
39 2021-01-11 numbness The numbness began to intensify and I could not feel myself blinking or smiling on the left side of ... Read more
The numbness began to intensify and I could not feel myself blinking or smiling on the left side of my face; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) via an unspecified route of administration on 07Jan2021 07:00 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was Workplace Clinic. Medical history included food allergy at shrimp. Concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 07:15 AM the patient notice pain and numbness to her left ear and left jaw that began to spread down left jaw and upward across left cheek, left eye, and left temple, and above left eyebrow. The numbness began to intensify and patient could not feel herself blinking or smiling on the left side of my face. The numbness slowly began improving over the next hour in the same order that it began, but she still have mild left ear and jaw pain and mild numbness. Events outcome are recovering. No treatment was received. The action taken was not applicable.; Sender's Comments: Based on the compatible time association, the facial palsy is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-11 dizziness dizziness, lightheadedness, tongue tingling
39 2021-01-11 pain in extremity, pain fever 101.7 for around 24 hours, headache body aches, arm pain and swelling
39 2021-01-11 feeling hot, tremor, feeling cold intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleepin... Read more
intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital. Medical history included obesity. Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins. The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.
39 2021-01-11 feeling cold, tremor, pain left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches... Read more
left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event "left arm is really sore" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.
39 2021-01-11 pain mild body aches; After first dose I only had pain at the injection site. After the second dose of th... Read more
mild body aches; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1685, intramuscular at left arm from 16Dec2020 11:30 to 16Dec2020 11:30 at a single dose then (lot number: EK9231) via an unspecified route of administration at left arm from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia. Concomitant medication included propranolol. After first dose on Dec2020, the patient only had pain at the injection site. After the second dose of the vaccine on 06Jan2021, the patient had pain at the injection site as well as mild body aches, chills and a fever of 101.5. The patient dis not received any treatment for the adverse events. The outcome of th events was recovering.
39 2021-01-11 tremor, tingling, feeling cold muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 10... Read more
muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 100s; SBP 147; left arm started to have tingling sensation. the sensation got worse as the minutes passed/tingling on right side of the face below eye; This is a spontaneous report from a contactable Nurse. A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular (left arm, dose 1) on 05Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. The patient previously took rocephine and experienced rash. On 09:03, patient received vaccine. On 09:07, left arm started to have tingling sensation. the sensation got worse as the minutes passed. On 0930; vital signs were taken (SBP 147, HR 100s). On 09:40, second set of Vitals (SBP 117, HR in the 80s). On 1028, tingling on right side of the face below eye. On 10:38, tingling on the face got better. Feeling shaky and cold. On 11:15, muscle joint pint in the fingers on left hand. On 13:30, most of the symptoms disappeared. Tingling on left arm still present mostly on in the tip of fingers and inner aspect of the forearm that comes and goes. Symptoms are not as bad as the first 50 minutes into the vaccine. Events occurred on 05Jan2021. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Event outcome was recovering. The reporter considered the events as non-serious.
39 2021-01-11 numbness, weakness, pain in extremity, lethargy swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch... Read more
swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received. No follow-up attempts are possible. No further information is expected.
39 2021-01-12 pain 11 hours after vaccine, chills started. Fever, chills, severe headache and body aches, and fatigue ... Read more
11 hours after vaccine, chills started. Fever, chills, severe headache and body aches, and fatigue over next 24 hours. Bedridden, would not have been able to work or care for my children. Left eyelid began twitching at that time and has continued to have intermittent periods of twitching over the 5 days since.
39 2021-01-12 pain Body aches; took Tylenol for relief, which helps temporarily.
39 2021-01-12 pain Called to report that the evening she received dose, she experienced extreme fatigue and body aches.... Read more
Called to report that the evening she received dose, she experienced extreme fatigue and body aches. Woke up during night on 1/12 with fever, chills, joint pain and body aches. Spoke with her this morning 1/13 and reports feeling better today other than fatigue. Plans to return to work 1/14.
39 2021-01-12 pain Chills, body aches, joint pain, headache, fatigue,nausea
39 2021-01-12 dizziness, lethargy, weakness Employee complained of dizziness after sitting for 10 min in observation area. Employee became letha... Read more
Employee complained of dizziness after sitting for 10 min in observation area. Employee became lethargic and was unable to stand. She complained of R side chest pain and R sided weakness. Symptoms did not go away. Employee sent to ER.
39 2021-01-12 tingling Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When... Read more
Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When I woke the next morning, my hands were red, swollen and extremely itchy and had whelps around some of the joints. This progressed up into my wrists and elbows as the day went on. This is similar to the symptoms that I experience when I had fifths disease.
39 2021-01-12 dizziness Patient developed numbness in her lips, had some tachycardia, and dizziness around 5:30 pm. Patient ... Read more
Patient developed numbness in her lips, had some tachycardia, and dizziness around 5:30 pm. Patient then notified one of the physician who advised her to monitor symptoms and notify on call provider if symptoms worsened. Patient then went home and slept and the next morning was feeling better.
39 2021-01-12 dizziness, feeling hot Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy.... Read more
Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy. Her face was very red. She was extremely hot. Patient first bp was 140/101 with a pulse of 75. We continued to monitor her for the next 1 hour and 20 minutes until family arrived because she refused for us to call 911 because she did not want a bill. Every time we sat her up she was extremely dizzy. BP was 160/107 when she sat up on the bed. Her husband ended up taking her to the ER because she was still very hot and dizzy. Dr. was here. He listened to her breathing multiple times. There was no signs of allergic reaction. Patient reported a history of panic attacks.
39 2021-01-12 vertigo Patient states she woke the morning after receiving her vaccine and felt disoriented for about 10 mi... Read more
Patient states she woke the morning after receiving her vaccine and felt disoriented for about 10 min, when she went to get out of bed she had severe vertigo and was unable to ambulate without holding on to furniture. She took over the counter vertigo medication which did not resolve her symptoms. She was unable to work. As of 01/13/21 patient continues to experience mild vertigo and now has fluid building up in left ear. Has called PCP and is waiting for direction.
39 2021-01-12 numbness, tingling Right sided facial tingling/numbness
39 2021-01-12 weakness, dizziness, lethargy Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss ... Read more
Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss of color in face and lips, headache, weakness, lethargy
39 2021-01-12 dizziness Severe pain in Right shoulder and inability to move arm more that 10 degrees with shoulder flexion o... Read more
Severe pain in Right shoulder and inability to move arm more that 10 degrees with shoulder flexion of abduction, nausea, vomiting, dizzy (beginning to pass out), chest pain, temp over 102, severe headache
39 2021-01-12 numbness The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later... Read more
The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later headache and left hand numbness
39 2021-01-12 feeling hot chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but n... Read more
chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but never had a temperature/ 99 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via unspecified route in the left arm single dose for COVID-19 immunization on 28Dec2020, 16:45 at 39-year-old. No medical history. Concomitant medication was not reported. No additional vaccines administered on same date of the vaccination or within 4 weeks before the vaccination. The patient had a little bit of chills on 31Dec2020. The chills was on and off, it may have even been on 01Jan2021. The patient occasionally felt warmer, but her temperature was normal. She felt warm inside her body or feverish on 29Dec2020 but never had a temperature. She still felt the chills and feverish on and off. She had it all day yesterday 05Jan2021. The temperature was 99 degrees Fahrenheit on 05Jan2021, but she had been working in the house. After she sat down for a while the fever went away. The chills and feeling like she might have fever are persisting through today. She didn't treat the chills or feverish in any way. No physician office or emergency room visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
39 2021-01-12 pain developed mild head ache and body ache around 7 pm on 1/11/2021, worsened after 7:30 pm with chills ... Read more
developed mild head ache and body ache around 7 pm on 1/11/2021, worsened after 7:30 pm with chills and fever and severe body ache through the night with mild congestion and more pronounced head ache by 1/12/2021. Took Tylenol to reduce fever. Fever and chills returned as medication effect reduces over 6 hours, it has continued today on 1/13/21
39 2021-01-13 dizziness After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and light... Read more
After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and lightheadedness. Patient was given water/juice. Patient was instructed to wait an additional 15 minutes for observation but declined and left against medical advice
39 2021-01-13 numbness Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and bu... Read more
Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and burning sensation when trying to breath. Severe sore throat Numb left had day of injection
39 2021-01-13 numbness Contract employee reports approximately 25 minutes after receiving her second covid vaccination she ... Read more
Contract employee reports approximately 25 minutes after receiving her second covid vaccination she began to experience mild numbness in and slightly below her right ear. She reports her hearing sounding "muffled" in her right ear. This employee was monitored for a total of 60 minutes in the observation area and reports no worsening of symptoms at the 60 minute mark and felt comfortable leaving the location. She reports having similar symptoms with the first Covid vaccination she received but denies reporting it to Employee Health department or submitting a report herself. She does state she reported the symptoms on the daily check-ins.
39 2021-01-13 weakness Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph node... Read more
Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph nodes on left side under arm; generalized weakness
39 2021-01-13 pain in extremity H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp, took Tylenol. Thi... Read more
H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp, took Tylenol. This AM still have H/A, sore arm, 98.8 temp. Pain in right upper arm.
39 2021-01-13 tingling, numbness Numbness tingling in feet, toes progressed to waist. ER Sunday hosp, pt was admitted inpatient, di... Read more
Numbness tingling in feet, toes progressed to waist. ER Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
39 2021-01-13 pain Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other ... Read more
Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, on 06Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included BNT162B2, intramuscular from 16Dec2020 to 16Dec2020 (1st dose; lot: PAA156051). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications. The patient experienced pain at injection site, body aches and headache. The outcome of event was recovering. No treatment received. No follow-up attempts possible. No further information expected.
39 2021-01-13 migraine Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Ras... Read more
Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), intramuscular, in the left arm on 23Dec2020 at 10:30 AM (at the age of 39-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient previously took prochlorperazine edisylate (COMPAZINE) and experienced drug hypersensitivity. On 23Dec2020 at 8 PM, the patient experienced rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The events were reported as non-serious. The patient did not receive any treatment for the rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The clinical outcome of the events rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-01-13 pain in extremity Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Profes... Read more
Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 22Dec2020 07:15 at a single dose for COVID-19 immunization at the hospital. Medical history included anxiety from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), escitalopram oxalate (LEXAPRO), birth control and unspecified MVI. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, fatigue and night sweats on 22Dec2020 with outcome of recovering. No treatment was given for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on batch/lot number was requested.
39 2021-01-13 tingling Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minute... Read more
Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minutes/ tingling on tongue & cheek; tingling on toes on right side of feet only/ tingling on foot; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female nurse (patient) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular route of administration on the left arm on 29Dec2020 10:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), vitamin B complex, zinc, and curcuma longa (TURMERIC), all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced tingling in side of tongue at 10 minutes after vaccine, tingling on right side of cheek at 45 minutes & tingling on toes on right side of feet only on 29Dec2020 10:15. The tingling on tongue & cheek went away, but she was still getting tingling on foot at times. This never happened to her before the vaccine. No treatment was given and events were reported as non-serious. The outcome of the event tingling on tongue & cheek was recovered on an unspecified date and of tingling on foot was not recovered. The patient had not been tested for COVID-19 since the vaccination.
39 2021-01-13 tingling, dizziness Tingling, lightheaded, SOB, diaphoretic. Administered 50 IM Benadryl and symptoms were not resolvin... Read more
Tingling, lightheaded, SOB, diaphoretic. Administered 50 IM Benadryl and symptoms were not resolving. Called EMS for transport to ED.
39 2021-01-13 pain in extremity Upper arms soreness; This is a spontaneous report from a contactable other hcp. A 39-year-old female... Read more
Upper arms soreness; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date: unknown, intramuscular (right arm) on 16Dec2020 07:30 at a SINGLE DOSE then the second dose via intramuscular (left arm) on 06Jan2021 08:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced upper arms soreness on an unspecified date with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-01-13 pain in extremity Upper arms soreness; Upper arms soreness; Chills; Headache; lower stomach and lower back cramping; l... Read more
Upper arms soreness; Upper arms soreness; Chills; Headache; lower stomach and lower back cramping; lower back cramping; fever 102; Fatigue; joint and muscle pain; joint and muscle pain; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-old female patient (not pregnant) received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), intramuscularly in left arm on 06Jan2021 08:00 AM at single dose for COVID-19 immunisation. Facility type vaccine was in hospital. Medical history included Sulfa allergy. There were no concomitant medications. The patient received the first dose of BNT162B2 on 16Dec2020 07:30 and experienced upper arms soreness. The patient didn't have other vaccine in four weeks or other medications in two weeks. The patient was not diagnosed with COVID-19 prior vaccination and didn't test COVID-19 post vaccination. After receiving the 2nd dose, the patient experienced upper arm soreness, chills, headache, lower stomach and lower back cramping, fever 102, fatigue, joint and muscle pain on 06Jan2021, 05:00 PM. No treatment was received for the events. Seriousness criteria was no. The outcome of the events was recovering. Information about lot/batch number has been requested.
39 2021-01-13 pain, dizziness Within minutes of getting the vaccine I had a brief(maybe 30 seconds) episode of dizziness. I didn't... Read more
Within minutes of getting the vaccine I had a brief(maybe 30 seconds) episode of dizziness. I didn't have any other symptoms during my 15 min observation period, but when I got to my car to leave the hospital, I had another episode of dizziness that lasted a couple minutes and then stopped. I didn't have any other incidents of dizziness, but started feeling fatigued and had chills that afternoon. Tuesday evening I had a slight fever, diarrhea, tachycardia, and palpitations. Over night I developed body aches. Most of the symptoms were pretty much gone within 24 hrs, but the fatigue and tachycardia lasted into Friday. My heart rate was consistently 115-125 bpm from Tuesday evening through Friday.
39 2021-01-13 pain felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; T... Read more
felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; Tested positive for COVID after receiving the first dose of the COVID Vaccine; slight fever; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (the patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) via unspecified route of administration on the left arm/shoulder on 22Dec2020 at single dose for COVID-19 immunisation. Medical history included gained weight since the pandemic started. The patient's concomitant medications were not reported. Patient received first dose of the vaccine. She had symptoms right after she got the vaccine the next day, on 23Dec2020. She had a slight fever, body aches, and a headache, which she never gets. She had these for about 2-3 days, they lingered around, and kicked back up around 26Dec2020/27Dec2020. She also felt kind of tired. She got covid 19 infection tested on 02Jan2021 and the results came back positive on 03Jan2021. Patient was calling to report this and see what to do about the second dose. She was supposed to get her second dose next Tuesday. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
39 2021-01-13 tingling, numbness, pain in extremity left arm was tingling; numb feeling all the way to fingers; pain in arm down to her finger joints; ... Read more
left arm was tingling; numb feeling all the way to fingers; pain in arm down to her finger joints; pain in arm down to her finger joints; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ES1685, via an unspecified route of administration in the left arm, from 08Jan2021 12:45 at a single dose, for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), dairy intolerance and perfume sensitivity. The patient's concomitant medications were not reported. On 08Jan2021 13:15, a half hour after the vaccination, the patient experienced that her left arm was tingling, a numb feeling all the way to fingers; it lasted about one hour after it came on, but now she have pain in arm down to her finger joints. The outcome of events was reported as recovered with sequelae. No treatment was received/given due to the events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
39 2021-01-13 pain in extremity pain down left arm and into the armpit/chest swelling in left supraclavicular area going on 7 days
39 2021-01-14 pain in extremity, pain 2ns shot -- headache that started shortly after the shot that worsened and was not alleviated with t... Read more
2ns shot -- headache that started shortly after the shot that worsened and was not alleviated with tylenol. headache lasted about 1.5 days. chills started at about 3 am on 1/13/2021 and lasted for about 1 day. body aches lasted for one day on 1/13. fatigue started on 1/13 and lasted through 1/14. painful left axillary lymph node swelling starting on 1/13 and continuing to present day. 1st shot -- sore arm, painful left axillary lymph node swelling
39 2021-01-14 dizziness DIZZINESS, HEART RACING
39 2021-01-14 feeling hot, feeling hot, feeling hot Employee reports sensation of significant warmth/heat that comes in waves. Vital signs checked: 10... Read more
Employee reports sensation of significant warmth/heat that comes in waves. Vital signs checked: 10:35- 144/95 1045- 137/89 1049- 123/90 Episodes of warmth would come in waves. Symptoms would resolve and then return. Improved after 35 minutes of observation
39 2021-01-14 pain Moderate Bilateral jaw pain with moderate headaches; started about 3-4 days after shot, persistent, ... Read more
Moderate Bilateral jaw pain with moderate headaches; started about 3-4 days after shot, persistent, constant- despite ice and ibuprofen. Pain is intense but manageable to go to work. I am getting really worried about this pain. No problem increased pain with eating, but or talking
39 2021-01-14 numbness Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would ... Read more
Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would feel like they were seizing up and clenching throughout the night; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration in left arm on 07Jan2021 18:30 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included Von Willebrand's disease. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen. On 07Jan2021 23:00, the patient experienced muscle pain, from lower back down, Muscles would feel like they were seizing up and clenching throughout the night, for a short time she had no feeling at all below the waist and incredible fatigue. The outcome of the events was not recovered. The patient was not tested for COVID-19 post vaccination. The events was assessed as non-serious by the nurse. The patient did not received any treatment for the events.
39 2021-01-14 dizziness, vertigo Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches... Read more
Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches in lower back; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via intramuscular on 07Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included asthma, hospitalized with pertussis related bronchiolitis/hypoxia in Apr2020. The patient's concomitant medications received within 2 weeks of vaccination included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products included erythromycin and pancuronium bromide (PAVULON). The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via intramuscular on 17Dec2020 17:00 at single dose in right arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, vomiting, dizziness with vertigo, headache, fever, severe body aches in lower back and fatigue from 36 to 50 hours post vaccination on 09Jan2021. The patient did not receive any treatments. The outcome of the events was recovered in Jan2021.
39 2021-01-14 tingling, numbness Numbness and tingling in left side of face starting on morning on 08Jan.; Numbness and tingling in l... Read more
Numbness and tingling in left side of face starting on morning on 08Jan.; Numbness and tingling in left side of face starting on morning on 08Jan.; This is a spontaneous report from a contactable Nurse, the patient. This 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK9231) dose #2, via an unspecified route of administration in the left arm on 06Jan2021 at 08:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. Medical history included guillain-barre syndrome from 2017 (reported as not related to a vaccine) and unknown if ongoing, asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing known, environmental allergy (unspecified) from an unknown date and unknown if ongoing known and an allergy to metals from an unknown date and unknown if ongoing known. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), montelukast sodium (SINGULAIR), drospirenone, ethinylestradiol betadex clathrate (YAZ), omeprazole (PROTONIX [OMEPRAZOLE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and mometasone furoate (FLONASE [MOMETASONE FUROATE]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), dose #1, via an unspecified route of administration in the left arm on an 19Dec2020 at 08:15 as a single dose for COVID-19 vaccination. On 08Jan2021 at 05:00, the patient experienced numbness and tingling in left side of face. No therapeutic measures were taken as a result of the events. The clinical outcome of numbness and tingling in left side of face was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-01-14 tingling On my way home from work about 20 min after 2nd vaccine unable to swallow and tingling/numb sensatio... Read more
On my way home from work about 20 min after 2nd vaccine unable to swallow and tingling/numb sensation to right side of face. Lasted approximately 30-45 min. Since then intermittent right sided facial tingling, lip twitching/numbness thats lasts approximately 2 seconds then stops. Increasing in frequency 1/15/21 which is leading me to report symptoms and notify PCP. Today (1/15/21) alone has happened about 20 times
39 2021-01-14 pain Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 12... Read more
Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 1200. Unable to move without pain rated 9/10. Tylenol and Motrin used PRN. Also noted fatigue and redness, swelling, pain at injection site. Called in to work 1/9/21 and 1/10/21. Pain continued rated at 8/10 until 1/12/21 when patient visited Urgent Care at 0930 . Provider gave 10mg oral Decadron and 30mg Toradol IM. Oral prednisone 50mg prescribed for 3 days starting 1/13/21. And continue regiment of tylenol, motrin, heat, bath for relief of symptoms. 1/13/21 patients lower back pain resolved. 1/14/21 patients left hip pain resolved. Right hip pain continues at same intensity, though somewhat more controlled with PRN tylenol, motrin, heating pad. Unable to work as of the submission of this report.
39 2021-01-15 pain Chills, headache, nausea at 2:00am, temp 101.3 at 4:30am with headache, body ache, nausea, fatigue. ... Read more
Chills, headache, nausea at 2:00am, temp 101.3 at 4:30am with headache, body ache, nausea, fatigue. Temp 101.4 at 10:30am with headache, body ache, nausea, fatigue. Temp 101.7 at 4:30pm with headache, nausea, body ache, fatigue.
39 2021-01-15 pain Im injection placed in shoulder not deltoid. National guard administering improper technique and a... Read more
Im injection placed in shoulder not deltoid. National guard administering improper technique and administration. He stuck me 2 times in my shoulder too high up. I have pain and very limited range of motion. I am unable to lift my arm 20%. So much pain and limited movement I sought care at ER.
39 2021-01-16 pain Approximately 15 hours after I received my second COVID-19 vaccination I developed chills and body a... Read more
Approximately 15 hours after I received my second COVID-19 vaccination I developed chills and body aches, which woke me up from sleep. When I woke up in the morning I had extreme fatigue; even walking to the bathroom was a challenge. I spent most of the day in bed, unable to do my normal daily activities. These symptoms lasted approximately 18 hours then completely resolved.
39 2021-01-16 weakness Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept... Read more
Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept for 9 hours. the next day began itching around the middle - stomach and back had to work so did not take anything for it. by the second day the itching was generalized. only temporarily relieved by application of cortisone - 10. the 3rd day I took cetirizine but it didn't seem to help much. the 4th day I took Benadryl and the itching reduced for the next few days. took another Benadryl on the 7th day. itching more localized to the stomach and back. Today, it came back to generalized again. from the scalp to the soles of the feet. I have to work so cannot take Benadryl at this time. Thought I would not need to see the Dr, hoping it would get better but as it stands today I will need to go see the Dr.
39 2021-01-16 weakness, migraine, dizziness Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, head... Read more
Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, headache started 12/20/2020, 4 days post the vaccine. Went to the ER on the 12/21/20-12/22/20 due to increase headache, vomiting, diarrhea, dizzy, dry cough, weak/extremely fatigue. At the ER was given IV fluid, Zofran, Phenergan, tested for the Flu and Covid, also had blood work. All my blood work came back in normal ranges, FLU and Covid test were negative as well. Discharged from the ER with Phenergan, the next 3 days I had a migraine and had to be in a dark room with lights off, still very dizzy, tired, shortness of breath with movement, could not eat it made me nauseas. Called for follow up with PCP he then put me on steroids, for 7 days. 12/28 called PCP office again, was put on another round of steroid treatment with antibiotic. Was off work from 12/21/2020-01/02/21 due to the sickness post the vaccine
39 2021-01-17 feeling of body temperature change Headache, muscle/body aches, hot and cold flashes, fatigue, and low grade fever.
39 2021-01-17 pain Nausea, body aches, extreme cold chills then hot flashes, heachache
39 2021-01-19 dizziness 39yo female with no documented allergies c/o being dizzy post vaccination with COVID19 Pfizer BioNTe... Read more
39yo female with no documented allergies c/o being dizzy post vaccination with COVID19 Pfizer BioNTech vaccine dose #1. No supportive treatment nor antidote given. Continued to state that she has mild pressure to her head. Ambulated without problem discharged to self.
39 2021-01-19 pain Around 12 hrs later, I started feeling general fatigue, chills, no fever and achy all over. Didn't ... Read more
Around 12 hrs later, I started feeling general fatigue, chills, no fever and achy all over. Didn't sleep well. I didn't take any meds since I'm pregnant. Symptoms peaked around 26 hours after vaccine. I slept almost all day. A very deep sleep. I started to feel a little better gradually. At 36 hours, I was completely back to normal. I am currently 31 weeks. I was 29 when I received the vaccine. Even with everything I experienced, I would do it again.
39 2021-01-19 pain Began having chills, fever 101.6, dry mouth, headache and body ache. Took ibuprofen and fever subsid... Read more
Began having chills, fever 101.6, dry mouth, headache and body ache. Took ibuprofen and fever subsided. Still having chills and extreme fatigue. Fever came back again.
39 2021-01-19 dizziness Caused my Fibromyalgia to flare, started have inflammation in my joints especially my ribs, headache... Read more
Caused my Fibromyalgia to flare, started have inflammation in my joints especially my ribs, headaches, dizziness, nausea, anxiety was also having RUQ pain which hasn?t been figured out yet. My bones and muscles and joints and tissue hurt.
39 2021-01-19 pain, pain in extremity Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feelin... Read more
Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feeling sore, legs hurt, and muscle aches Today Day 9 legs still sore and muscle aches, and fatigue Taking Benadryl at night for itching due to hives and Tylenol for soreness and muscle aches
39 2021-01-19 pain, pain Fatigue, body aches, injection site pain, headache
39 2021-01-19 pain Headache, fatigue, fever (102), chills, body aches, joint pain
39 2021-01-19 dizziness, feeling hot Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hour... Read more
Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hours after the vaccine, headache, nausea, dizziness continued. Face and left arm (vaccine site) felt like they were internally on fire. Twenty-four hours after the vaccine, flu-like symptoms (cold chills, fever, nausea, muscle aches to the point of it hurting to move, joint pain), headache, skin itching. Treatment was tylenol, ibuprofen, and benadryl.
39 2021-01-19 pain No adverse eventa occured after first vaccine. Three hours after second vaccination I started to fee... Read more
No adverse eventa occured after first vaccine. Three hours after second vaccination I started to feel adverse reactions. It started with sore throat, tiredness, body ache. Next morning work up with swollen lymph nodes, body ache, tiredness, headache, and the chills. Today feel alot better and adverse reactions have seem to subside.
39 2021-01-19 unresponsive to stimuli, weakness Patient received Vaccine and during observation period began starring forward and not responding to ... Read more
Patient received Vaccine and during observation period began starring forward and not responding to staff. Patient was taken to the emergency room and evaluated and noted to have a flat affect and general weakness. Patient did not loos consciousness or have any signs of distress. Was admitted to the hospital and noted that she had been in out of country for a week (possibly had cosmetic surgery)
39 2021-01-19 weakness Symptoms have worsened. I have an electric feeling in my legs and I am a lot weaker. I am waiting fo... Read more
Symptoms have worsened. I have an electric feeling in my legs and I am a lot weaker. I am waiting for an appointment with a neurologist. I also have a wheelchair that was donated.
39 2021-01-19 pain in extremity day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring ... Read more
day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring rescue inhaler. Fatigue and general malaise continued x 7 days with intermittent shortness of breath requiring use of rescue inhaler. (Prior to vaccine inhaler used 3/year post vaccine requiring inhaler 2x per day). Increased post nasal drip with shortness of breath at night 02-03am each night and head congestion ear fullness during day requiring rest increased benadryl and decongestant use.
39 2021-01-19 pain in extremity, pain fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L ... Read more
fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L arm
39 2021-01-19 pain fever, aches, vomiting headache
39 2021-01-19 pain, pain in extremity sore arm, chills, low grade fever, body aches, fatigue
39 2021-01-20 pain, weakness diarrhea; weakness; fatigue; low grade fever/my fever reached 102; body aches; This is a spontaneous... Read more
diarrhea; weakness; fatigue; low grade fever/my fever reached 102; body aches; This is a spontaneous report from a contactable Nurse(patient). A 39-year-old female patient received first dose BNT162B2 (lot number EJ1685) , via an unspecified route of administration at Arm Left on 20Dec2020 12:15 at the 39 years old at single dose for COVID-19 immunization. The medical history included septic shock, from 2014 multi organ failure. There were no known allergies. The concomitant medications were topiramate(TROKENDI), lisdexamfetamine mesylate(VYVANSE), bupropion, sertraline, paracetamol(TYLENOL). On 22Dec2020 12:00 the patient started to have a low grade fever and body aches. On 23Dec2020 12:00 her fever reached 102 Fahrenheit, she had body aches, diarrhea, weakness and fatigue. This continued until 27Dec2020. The patient took Tylenol and Advil for fever. Tylenol and Advil helped some with fever but not always. There was no treatment received for body aches, diarrhea and weakness and fatigue. The events low grade fever, fever reached 102, body aches, diarrhea, weakness and fatigue resulted in Emergency Room Visit. There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The outcome of the events was recovered on 27Dec2020.
39 2021-01-21 pain -fever of 102.8 -body aches -pain under injected arm -chills -tired
39 2021-01-21 tremor Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain , muscular pain and tight... Read more
Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain , muscular pain and tightness throughout body. In middle of night started vomiting . Approx 6am called primary MD. Was instructed to go to nearest hospital.
39 2021-01-21 pain Fever, body aches , joint pain, dry cough, loss of taste of spice only. All symptoms resolved except... Read more
Fever, body aches , joint pain, dry cough, loss of taste of spice only. All symptoms resolved except loss of taste of spice. COVID test neg.
39 2021-01-21 pain in extremity, pain Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At inject... Read more
Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At injection site
39 2021-01-21 pain in extremity I noticed the night of 1/21/2021 that my arm was itchy. Looking at it there was a red raised bump at... Read more
I noticed the night of 1/21/2021 that my arm was itchy. Looking at it there was a red raised bump at the injection site that had not previously been there. Since having the vaccine the only other effect I had was arm soreness the day of and day after the shot.
39 2021-01-21 tenderness, swollen extremities Left axillary lymphadenopathy. Tender. Gradually improved over 10-14 days. Still single enlarged but... Read more
Left axillary lymphadenopathy. Tender. Gradually improved over 10-14 days. Still single enlarged but non-tender mobile lymph node on date of report (1/21/2021)
39 2021-01-21 pain in extremity, pain Received the vaccine at 9:30.am on Wednesday. By noon on Thursday,felt soreness in arm. By 6pm, I f... Read more
Received the vaccine at 9:30.am on Wednesday. By noon on Thursday,felt soreness in arm. By 6pm, I felt a heaviness in every muscle- had to go to bed. Took Advil and had a good nights rest. Woke up the next morning, feeling better but I started feeling fatigued and achy by noon. I had to leave my job and went home and slept for 3 hours. Had dinner but had to go back to bed due to fatigue. Took Advil and Tylenol and feeling better on Friday morning.
39 2021-01-24 pain 1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdo... Read more
1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.
39 2021-01-24 dizziness, pain in extremity, pain Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fat... Read more
Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
39 2021-01-24 pain chills, fever (highest 102.8), body aches onset around 1am (approx 16 hrs after receiving dose); wok... Read more
chills, fever (highest 102.8), body aches onset around 1am (approx 16 hrs after receiving dose); woke up around 5am and fever had come down; by the time I awoke again at 11am I felt very tired but all other symptoms had resolved
39 2021-01-25 numbness, tingling 1/15/21 Tingling in lips, fingers and arms 1/16/21 Right sided facial numbness
39 2021-01-25 pain 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After t... Read more
12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; breastfeeding; breastfeeding; This is a spontaneous report from a contactable other healthcare professional (HCP). The reporter reported for herself and her child. This is the mother report. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included breast feeding from an unknown date and unknown if ongoing. The patient previously took BNT162B2 on 18Dec2020. The patient stated on 08Jan2021, 12 hours after the second dose, she experienced body aches, low grade fever for about 6 hours. After that she had upper and lower back pain, neck pain and a mild headache. She took Advil and felt normal shortly after for the rest of the day and there after. She would categorize my symptoms as mild. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030867 Parent/fetus cases.
39 2021-01-25 dizziness 1:08 Injection; 30 min wait time , 1:40 Tingly lower lip and dizzy 1:45 Benadryl 50mg; bp 122/7... Read more
1:08 Injection; 30 min wait time , 1:40 Tingly lower lip and dizzy 1:45 Benadryl 50mg; bp 122/72 HR 83, pox 99 2pm still dizzy ", somewhat ; somewhat less tingly lip" couldn't give a scale 2:20 per DNS Deb, improved slightly. 2:30 very tired - may be contributed to 50mg Benadryl. 2:30 medical director examined. She feels okay, sent home with another staff member. Suggest contact her dr tomorrow and before next vaccine. Suggest do it at a medical facility.
39 2021-01-25 pain in extremity A swollen armpit; Arm hurts; This is a spontaneous report from a Pfizer-sponsored program. A contact... Read more
A swollen armpit; Arm hurts; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient's arm hurts on 08Jan2021 and developed a swollen armpit on 10Jan2021. The outcome of swollen armpit was not recovered while arm hurts recovered on 10Jan2021.
39 2021-01-25 pain in extremity I had left wrist pain distributed up my arm that was severe for 4 days, I've had issues with that be... Read more
I had left wrist pain distributed up my arm that was severe for 4 days, I've had issues with that before and that seemed to flare it. I took Tylenol and rested it and it got better after about 4 days, I saw the Dr 5 days later and he gave me a splint
39 2021-01-25 numbness Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued u... Read more
Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued up both legs and then weakness set in. Called PCP on the 15th as symptoms were getting worse not better. Patient advised me to go to ED. Went to ED here last Friday and was released. The weakness in legs got much worse and early the following week she started getting the numbness and weakness in arms. She went for the follow up post ED visit with NP at PCP office on 1/20 and due to the continued weakness, after consulting with one of the MDs, decision was made to send her back to ED for further work up to check for GBS including the LP in ED, labs and MRI of head, spine, lumbar and thoracic. Patient was release on Saturday 1/23 and diagnosis was a severe immune response to the vaccine. Patient still has unsteady gait and weakness.
39 2021-01-25 pain SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES... Read more
SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES. FEVER FLUCTUATING BETWEEN 99.4 AND 101.2. TOOK IBUPROFEN EVERY 4 HRS AS NEEDED TO REDUCE FEVER.
39 2021-01-25 pain in extremity Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/c... Read more
Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/congestion and cough; Tested positive for COVID-19 on 03Jan2021/congestion and cough; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This 39-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via intramuscular at left deltoid on 28Dec2020 11am at single dose for COVID-19 immunization. Medical history included non-smoker with no other illness. Concomitant medication was none. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient reported after receiving her first dose of the COVID-19 vaccine on 28Dec2020, she had sore arm and a little tired, other than that felt fine. She stated second dose was due 25Jan2021. She was tested positive for COVID-19 (Rapid Covid testing) on 03Jan2021. She already decided going to wait the 90-day-period to get the second dose of the vaccine. Since she was quarantined she wanted to what she should do. She stated her having testing positive for Covid did not have anything to do with the vaccine. She still had some lingering symptoms, congestion and cough. Nothing had worsened, but just wouldn't go away. She did not receive any other vaccines the same day or 4 weeks prior. No history of problems with vaccines in past. She had not had antibodies checked yet. It was reported no AE required a visit to emergency room/physician office. The patient was not hospitalized. The patient received no additional therapies for COVID-19. Patient's outcome with COVID-19 was recovering, and the rest of events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID-19 (Rapid Covid testing), which is considered ineffective of BNT162B2, and the administration of BNT162B2.
39 2021-01-25 pain in extremity, pain Woke up with a low fever, body aches, left arm pain and a little headache after taking the 2nd Covid... Read more
Woke up with a low fever, body aches, left arm pain and a little headache after taking the 2nd Covid vaccine dose. I took Tylenol and my fever and body aches went away. Still got a minor headache and left arm pain.
39 2021-01-26 pain Body aches; Exhaustion/fatigue; Low grade fever; Headache; Foggy; This is a spontaneous report from ... Read more
Body aches; Exhaustion/fatigue; Low grade fever; Headache; Foggy; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142) intramuscular in Left arm on 12Jan2021 08:30 at single dose for COVID-19 immunisation. She received the first dose (lot number=EJ1685) intramuscular in left arm on 22Dec2020 08:30 AM at age of 38 years old for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medication included phentermine. On 12Jan2021 21:30, the patient experienced body aches, exhaustion/fatigue, low grade fever, headache, foggy. No treatment received for events. The patient was not pregnant. Events outcome was recovering.
39 2021-01-26 pain I had a fever, fatigue, achy , night sweats.
39 2021-01-26 pain I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection si... Read more
I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection site.
39 2021-01-26 migraine L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pr... Read more
L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
39 2021-01-26 difficulty speaking Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started ... Read more
Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started after obs, "feeling unwell" so patient returned to obs for additional 15 min. Cleared to RTW. After eating, @6 p.m. patient noted difficulty swallowing in evening & change in voice so she thought she had throat swelling. Took Benadryl 25 mg PO and Tylenol rapid release for HA. Hives resolved that evening and patient went to sleep. Over the weekend, had flu like symptoms, nausea, fatigue, HA. Took Benadryl 12.5 mg PO on 1/23 and continued Tylenol through weekend. 1/26 - 1/27: Signs and symptoms resolved
39 2021-01-26 nerve pain Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surfa... Read more
Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surface; Severe joint pain; Muscle aches; Swollen lymph nodes; Headache; Fatigue; Upper body sporadic shivering; Interval between the first and second doses of BNT162B2 is 27 days; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 14Jan2021 at 17:15, at a single dose, for COVID-19 immunization. The patient's medical history included sporadic neuralgia, numbness to patches on legs, shift-work sleep disorder, and generalized anxiety. The patient's concomitant medications included armodafinil (NUVIGIL), paracetamol (TYLENOL), and alprazolam (XANAX). The patient previously took ferric subsulfate (MONSELS Solution) and experienced allergy; and the first dose of BNT162B2 (Lot Number: EH9899) on 18Dec2020 (6 PM) for COVID-19 immunization (in left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 14Jan2021 (05:15 PM), the interval between the first and second doses of BNT162B2 is 27 days. On 15Jan2021 at 9:15 AM, the patient experienced severe neuralgia pain over 75% of her skin surface beginning at 14 hours post-second dose (as reported) and still continuing now at 30 hours post-dose. Also, the patient experienced severe joint pain, muscle aches, swollen lymph nodes, headache, fatigue, and upper body sporadic shivering (not cold). It was unknown if the patient received treatment for the events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
39 2021-01-26 pain, tremor, weakness The next morning after my vaccine I went into work feeling a little achy and a slight headache then ... Read more
The next morning after my vaccine I went into work feeling a little achy and a slight headache then by 8:00am I felt like a train hit me, my body was chilling, shaking despite being in front of a heater, I had a low grade fever, my right side of my head hurt so incredibly bad like my right eye was going to explode, I then started vomiting. My boss came to help walk me outside because I didn?t even feel like it was me walking. I don?t remember walking out of work. I was there but ?not there?. I was not myself. I didn?t feel like i was in my body. I had to have my husband come get me from work, I slept most the rest of the day and night. Now I?m on day 2 and my joints still ache, my head hurts so bad, I am so tired I either am asleep on the couch or in bed. I have no energy. It takes everything I have to move just to go to the bathroom.
39 2021-01-26 pain in extremity diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site ar... Read more
diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site around 10pm. Took Tylenol. Had slight pain to forehead around 8pm started to bruise. Saturday woke up with slight pain to arm/left side of neck. Bruise larger today. Saturday evening swollen. Lots of pain and trouble turn head. Left side neck/shoulder area pain. Applied ice/took Advil. At times hard to move arm, neck. bone pain by injection site. Now had pain from elbow to neck area, and shoulder on left arm for about 5 days now. At times pain feels like my bones hurt in those areas. Still swollen with bruising. Using pain meds ever 4 hours. And placing hot/cold packs with little relief.
39 2021-01-27 feeling hot 39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms we... Read more
39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms were red. Upon questioning she reported she felt hot and itchy. Upon request she removed her jacket. Vital signs normal. She self-administered 25 mg of Benadryl. About 10 minutes later she reported developing a headache but otherwise reported some improvement in feeling hot and her facial/arm redness improved. She was originally given discharge instructions including home precautions and released to self, however a few minutes after leaving the patient walked back into the vaccination site and reported itching in throat with clearing throat. Patient was administered epinephrine 0.3mg IM and transferred to ER via EMS.
39 2021-01-28 pain in extremity 10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I w... Read more
10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I was short of breath and had nausea and a headache. This lasted for 1.5 hrs. then I laid down. As I was falling asleep I couldn't shake a scary "vision: I was having of myself like my eyes turning bright blue and electricity going through my body and my body ascending into the air. I had nightmares all night. I have never had hallucinations or whatever that was. And nightmares are rare for me. I woke up fine on day 2, just a stiff sore arm. Day 3 I was fine. Day 4 I am developing an itchy, bumpy, rash on my right arm at site of injection and around it. I reported this online on my health chart and will go in if I keep getting strange reactions.
39 2021-01-28 dizziness Had COVID December 19, 2020. Had 1st dose Pfizer on 1/6 and 3 hrs after had heart palpitations, dizz... Read more
Had COVID December 19, 2020. Had 1st dose Pfizer on 1/6 and 3 hrs after had heart palpitations, dizzy, HR 110-115. Lasted for 48 hours intermittently. 1/29 15 minutes after 2nd dose was dizzy. @ 1120 B/P 110/79 sats 100%, HR 67, @1126 B/P 107/80, HR 72. Stayed for 40 minutes and left feeling fine. Takes no meds, In 2002 had GI Ulcers and was treated and Allergic to Proton Pump Inhibitors- hives, heart palpitations, generalized swelling, dyspnea
39 2021-01-28 dizziness Patient complained of right sided throat swelling that started 15 minutes after receiving vaccinatio... Read more
Patient complained of right sided throat swelling that started 15 minutes after receiving vaccination. She also reported dizziness and nausea. She denies rash, hives, shortness of breath, tongue swelling, lip swelling, and any other symptoms. Patient received 50mg of Benadryl and 50mg of Solu Medrol upon arrival to ED which improved her symptoms.
39 2021-01-28 numbness, tingling by night bilateral arm heaviness; 8 days out: right forearm weakness paresthesia/pins and needles se... Read more
by night bilateral arm heaviness; 8 days out: right forearm weakness paresthesia/pins and needles sensation across neck shoulders extending to upper arms; 7 days after 2nd injection right foot/calf numbness; quadriceps weakness/11 days out left quadriceps weakness; This is spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hypothyroidism and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), colecalciferol (VITAMIN D), and ubidecarenone (COQ10). Patient previously received the first dose of BNT162B2 on 15Dec2020 09:00 in right arm for COVID-19 immunization. 7 days after 2nd injection right foot/calf numbness quadriceps weakness on 12Jan2021 21:00. 8 days out: right forearm weakness paresthesia on 13Jan2021. 11 days out left quadriceps weakness, by night bilateral arm heaviness on 16Jan2021. 12 days out pins and needles sensation across neck shoulders extending to upper arms on 17Jan2021. Deep tendon reflexes intact throughout. Bladder function intact. Events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was not received for these events. Outcome of events was not resolved. Information about lot/batch number is requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-28 pain fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This i... Read more
fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 13Jan2021 09:45 at single dose in left arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no covid prior vaccination and no covid tested post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), via an unspecified route of administration on 23Dec2020 14:45 at single dose in left arm for COVID-19 immunization. The patient experienced pain at injection site, chills, body aches, headache, neck pain, joint pain, nausea, fatigue on 14Jan2021 02:00. The outcome of the events was recovered in Jan2021. The patient did not receive treatment for the events. No follow-up attempts are possible. No further information is expected.
39 2021-01-28 swollen extremities the right side swelling, swelling underneath armpit, swelling of collarbone and neck; This is a spon... Read more
the right side swelling, swelling underneath armpit, swelling of collarbone and neck; This is a spontaneous report from a contactable Nurse reporting for herself. A 39-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL0142) vaccine, intramuscular on 12Jan2021 15:30 at single dose for Covid-19 immunisation. Medical history included deep vein thrombosis, provoked DVT, and moderate asthma . There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 23Dec2020. The patient experienced right side swelling on 12Jan2021 some hours after injection. On 13Jan2021 swelling underneath armpit was significant, swelling of collarbone and neck was also present. The reported event was considered Important Medical event. The outcome of the event was recovering. The event was treated with Round the clock Ice pack. Antihistamine and NSAIDs. Followup information has been requested. Lot number already provided.; Sender's Comments: Based on the compatible temporal association, a contributory role of suspect vaccine BNT162B2 in the development of "the right side swelling, swelling underneath armpit, swelling of collarbone and neck" cannot be excluded. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-29 numbness, facial paralysis, slurring G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and ... Read more
G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and liquid came out my mouth spontaneously, my left side of face had lost normal wrinkles on forehead, eyebrow wouldn't lift, eyelid wouldn't blink, cheek couldn't puff, lips didn't smile. Next day (1) slight cheek numbness noted- resolved Day3 . Day 2 slight difficulty articulating words. Night 3 intermittent sharp outer ear and mastoid area pain duration 30min and at different times intermittent pulsatile heartbeat and whistling sound 10 min or less. Day 4 & 6 notable improvements in cheek ability to puff- not fully resolved though. Day 5 eyelid movement - not fully resolved though. Day 6: less difficulty articulating. Day 1: Spoke to OB office nurse- offered steroids which I declined & spoke to PCP recommended go to ED, which I declined, I'm a family physician and had otherwise normal Cranial nerve testing and no other neurological changes- seems fully consistent with Bell's palsy. Day 3 had co-worker physician use otoscope - normal exam bilaterally.
39 2021-01-31 tingling, numbness Progressive body numbness and tingling from chest down, unable to feel when urinating or have a bowe... Read more
Progressive body numbness and tingling from chest down, unable to feel when urinating or have a bowel movement, tight girdle banding feeling on and around chest and back, hand malfunction with drawing, unable to walk without cane/walker, feeling of walking on a bounce house as walking
39 2021-02-01 numbness Early Bell's Palsy; Facial numbness on the left side of her face; Facial numbness on the left side o... Read more
Early Bell's Palsy; Facial numbness on the left side of her face; Facial numbness on the left side of her face; Facial numbness and increased sensitivity on the left side of her face; This is a spontaneous report from a pharmacist. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at left arm on 06Jan2021 17:00 at single dose for covid-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, factor V leiden, gastroesophageal reflux disease (GERD), history of deep vein thrombosis (DVT), hypertension, neck pain on left side, rhinitis, rhomboid muscle strain and pain. No known allergies. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone for pain, sodium chloride. The historical vaccine included the first dose of BNT162B2 (Lot number: EJ1685) via intramuscular at left arm on 17Dec2020 04:15 PM and the paitent did notice some numbness on the right side of face after receiving the first dose of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial numbness and increased sensitivity on the left side of her face. There was no facial droop or lid lag. Other cranial nerves are stable. Concern for early Bell's Palsy would be treated with valganciclovir and prednisone. The adverse events (AE) started from 15Jan2021 09:00. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment valganciclovir 1gm q8h, prednisone 20mg 3-day taper for AE. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.; Sender's Comments: Based on the temporal relationship, the association between the event early Bell's paly with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-02-01 pain Reported feeling achy and fever of 101.2F.
39 2021-02-02 numbness, facial paralysis some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a con... Read more
some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular in the left arm on 17Dec2020 16:15 at a single dose for COVID-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, Factor V Leiden, GERD (Gastroesophageal reflux disease), DVT (deep vein thrombosis), hypertension, neck pain on left side, rhinitis, and rhomboid muscle strain. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone nasal spray, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone, and sodium chloride nasal spray. The patient had no other vaccines in four weeks before covid vaccine. The patient had no prior vaccination and she had not been tested post vaccination. The patient noticed some numbness on the right side of face after receiving the first dose of vaccine on an unknown date. She was concerned for early Bell's Palsy on 15Jan2021 at 09:00 AM. She will be treated with valganciclovir and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events early Bell's Palsy and some numbness on the right side of face was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "concerned for early Bell's palsy". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-02-03 pain in extremity I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of... Read more
I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of the pain, I have taken ibuprofen few times but it calms me down for a few hours, yes I can lift my arm and move it but I feel pain and discomfort all the time.
39 2021-02-04 weakness severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontane... Read more
severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 06:45 at single dose (vaccine location=right arm) for covid-19 immunisation. The patient medical history was not reported. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received first dose of BNT162B2 on unspecified date at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient experienced severe fatigue, chills, fever, rigors, myalgia, global weakness, sweating and nausea on 21Jan2021 07:00 PM. It was unknown if treatment received for events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-02-05 feeling hot Adverse event happened immediately after injection. Heat wave, rapid heart rate, increase respiratio... Read more
Adverse event happened immediately after injection. Heat wave, rapid heart rate, increase respirations, feeling of water dripping inside my arm, High Blood Pressure. Since then I have had feelings of "vibrations" running up and down my spine, arms, head, neck, chest, legs. I have been to the Chiropractor, Urgent Care Clinic, PCP, ER. Waiting to see a Neurologist... All of these symptoms happened after the 1st dose of the covid vaccine, and have worsened each day since. January 18 2021 to Current date. I have a detailed list of times, dates, and actions.
39 2021-02-07 pain, dizziness cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a ... Read more
cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was pregnant. The patient received the first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 for covid-19 immunization. On an unknown date in Jan2021, the patient experienced Dizzy head and sore. Then injection site swelling and was hot to the touch and a few lymph nodes reacted. Two days of 102+ fever, diagnosis of cellulitis in arm. Antibiotics received for cellulitis. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.
39 2021-02-08 one side paralysis Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusi... Read more
Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusitis. She has NKDA. Her medications prior to event included alprazolam 0.25mg Qday, citalopram 20mg, 1 and ½ tabs Qday, Topamax 25mg, 3 tabs Qday and Zyrtec 10mg Qday. She was administered her first dose of the Pfizer COVID vaccine on 1/21/21 at 1:30pm. She presented to the hospital on 1/22/21 @ 9:45am with acute onset of right sided weakness (she is a teacher who collapsed in her classroom without LOC) and was found to have a intraparenchymal hematoma (IPH) in the left posterior paramedian frontal lobe measuring up to 2.9 x 1.8 x 3.4cm with surrounding vasogenic edema and mild local mass effect with no underlying mass lesion or vascular malformation on MRI. She stated that she has had intermittent headaches over the last few weeks not similar to her prior migraines, although with no neuro deficits. She was also noted to have a urine tox screen positive for amphetamines. There is a confirmatory test pending. She was discharged to acute rehab on 1/25/21. Patient is still recovering from the adverse event. She did not receive any other vaccines within a month prior to the event.
39 2021-02-09 pain, pain in extremity, weakness Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the... Read more
Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the body aches were progressively worse and concentrated on left side of body. Joints were affected including left wlbow, wrist, shoulder. Hot viral rash appeared on arm right above left elbow that became painful with swelling and erythema. In Sunday through the following Wednesday, joint pain continued to worsen and settle in additional joints including first 2 metacarpal bones of both hands almost like arthritic pain. Fingers and joints red and swollen. Pain and swelling next settled in toes of both feet, right side elbow, shoulder and knee. On Monday following vaccine I called employee health and they advised me to come and take covid test. I described symptoms and was told they were side effects of the vaccine and to follow up with a doctor if it continues. My covid test was negative. On the following Thursday I went to urgent care and described my persisting symptoms. I was prescribed a methylprednisolone pack and hydroxyzine. I was told to use naproxen as needed. Yesterday the urgent care sent a check up message. I am still experiencing joint pain although the intensity has decreased but it is still significant pain that is disabling my grip and strengrh overall. The joint pain is mostly just in my upper extremities, hands, fingers and shoulders now consistently. The np prescribed a 10 day pack of meloxicam to try and help minimize the pain.
39 2021-02-10 one side paralysis, facial paralysis, tremor, inability to speak, slurring Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later h... Read more
Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later her arm was shaking uncontrollably, she felt that her throat was closing and had chest pressure. Medics noted hives and a rash on her chest and administered Epi and Benadryl. She began exhibiting stroke-like symptoms of expressive aphasia and dysarthria in the medic?s truck around 1850. She was crying and unable to speak. She had right sided facial droop, right sided grip weakness, and right sided arm drift. Patient was transferred to MC. Patient Update: Patient received tPA on 2/9 at 1949. CT revealed no hemorrhage or large territory stroke and no large vessel occlusion. NIHSS on admission to MC was a 3. Patient was also assessed by speech pathology. Patient appears to have been discharged home on 2/10. Patient to follow up with Outpatient Neuro PT Rehab as she is having some issues with mobility, gait, and overall functional mobility. She is using a 2 wheeled walker at this time.
39 2021-02-11 pain in extremity I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headach... Read more
I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headache; had nightmares all night; stiff, sore arm; stiff, sore arm; my arm has a bumpy, red mild rash at and around injection site; my arm has a bumpy, red mild rash at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 39 years) as a single dose in the right arm for COVID-19 vaccination. Medical history included fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient reported that on 27Jan2021 at 12:30 AM, approximately ten hours after the vaccine, the patient experienced a rapid and hard heartbeat, shortness of breath, nausea and headache. These lasted for one and one half hours. As she lay down falling asleep she got a strange vision/hallucination (this had never happened to her before) of her eyes turning lightning blue and her body rising up in the bed. She stated that she does not take medications or drugs and does not have a history of mental illness. She could not shake the vision. She fell asleep and had nightmares all night and nightmares are rare for her. One day two she woke up fine just a stiff, sore arm. On day three her arm has a bumpy, red mild rash at and around injection site. The patient did not receive any treatment for the events. Lab data included a COVID SARS CoV-2 positive test on an unspecified date. The clinical outcomes of hallucination, heart rate increased, shortness of breath, nausea, headache, nightmares, pain in arm, limb stiffness and vaccination site rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-02-15 weakness 1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test w... Read more
1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test which was negative, 1/22/21 still has fever drive thru at hospital covid drive thru pt had PCR and it was also negative, went back to same drive thru on 1/24/21 and had another PCR which was negative, 1/25/21 urgent care visit, pt was tested for flu-Negative, lab work was done which showed CBC all counts were low resulted in ER visit, admitted 1/25/21 afternoon with panside apnea and sepsis and patient stayed in hospital for 9 days 2/2/21 pt was released to go home. Lots of labs and test were done while patient was inpatient, Pt is still weak and has no energy.
39 2021-02-17 tremor Throat tight, hard to swallow, extreme dry mouth, chills, shaking, anxiety
39 2021-02-17 tingling, feeling hot pain in the left scapula area; a sensation of her body "vibrating" down the left arm; I felt: hot, a... Read more
pain in the left scapula area; a sensation of her body "vibrating" down the left arm; I felt: hot, a water dripping sensation inside my left arm; elevated BP; elevated pulse; elevated respirations; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration on 18Jan2021 09:00 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: Latex and causes a rash. Concomitant drugs included women's 1 a day multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Immediately after administration of the Covid-19 Vaccine on 18Jan2021, the patient felt: hot, a water dripping sensation inside my left arm, elevated BP, elevated pulse, and elevated respirations. On 22Jan2021 02:00 the first morning she noticed pain in the left scapula area, and a sensation of her body "vibrating" down the left arm. Each day the "vibrations" have worsened from 1 arm, to both arms, to up and down her spine, to up her neck, and some days even her face. She got NO relief from the "vibrations". They are constant 24 hours a day. She had been to the chiropractor, urgent care, and the ER. She had physician consults, blood work, x-rays, and CT Scan. It is effecting her life. She had NO relief, and got answers that she just had anxiety. This is not just anxiety. There is something wrong with her, and the only change in her life, has been to receive her covid vaccine. Medications have been given to help mask the symptoms, but they are still present, and are never changing or ending. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and considered as disability condition. No treatment was received for events (except event a sensation of her body "vibrating" down the left arm) The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
39 2021-02-19 facial paralysis, numbness Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles fo... Read more
Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles followed an hour later. Paralysis of eyelids followed. Medical staff on-site were not informed on how to proceed and recommend to take a benadryl and sleep it off. Muscle function returned 12 hours later.
39 2021-02-22 pain, nerve pain Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after... Read more
Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after first injection and second injection Body aches for 3 days Nauseous day 3 Dizzy day 2 and 3 Hives/itchy rash started day 2 and currently still have itching rash all over body.
39 2021-02-23 pain 2 days after the vaccine I developed a rash around the injection site 2/6/2021. After three days the... Read more
2 days after the vaccine I developed a rash around the injection site 2/6/2021. After three days the rash was gone without treatment. Then on 2/14/2021 I started feeling burning pain all over my neck and chest. It was slightly red that night. The next morning my chest, neck, and upper back had a red rash . My chest was the worst of it. Felt like a chemical burn . I went to the Doctor on 2/17/2021 and was told it was a delayed hypersensitivity reaction to the vaccine. I continued to take Benadryl, Zyrtec and was given Kenalog. On Sunday 2/21/2021 the pain was so pain and the rash was only getting worse and now on my face so I went to urgent care. There I was given a steroid ( prednisone) , derma smoothe and Pepcid. It has been 10 days and no improvement yet.
39 2021-02-25 slurring, tremor, seizure convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her... Read more
convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae.
39 2021-02-28 tingling patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse ... Read more
patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.
39 2021-03-01 feeling hot, pain breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line ... Read more
breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line traveling to my armpits; breast became red, sore, warm and had a line traveling to my armpits; breast became sore, warm and had a line traveling to my armpits; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose (BNT162B2, Pfizer, Solution for injection, lot number: EL3249, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 19Jan2021 06:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient medical history was not reported. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There were no other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Pfizer, lot number: EL1284) on 30Dec2020 06:00 (vaccine location: left arm). On 24Jan2021, the patient started to have left breast pain. Her breast became red, sore, warm and had a line traveling to the armpit. The doctor stated the red area felt full. The patient was treated for a breast infection. Treatment received for the adverse events included: Clindomycin. The events were considered non-serious by the reporter. The events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient had not been tested for COVID-19. The events recovered on an unspecified date in 2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event mastitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-03-04 pain Heavy headed; Sore; so tired that could only sleep; Felt unwell; Extreme tiredness/so tired that cou... Read more
Heavy headed; Sore; so tired that could only sleep; Felt unwell; Extreme tiredness/so tired that could only sleep; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), via an unspecified route of administration in the left arm on 29Jan2021, at 14:15 as single dose for covid-19 immunization. Medical history included allergy to mangos from an unknown date. The patient felt unwell on 01Feb2021 with outcome of not recovered; extreme tiredness/so tired that could only sleep on 01Feb2021 with outcome of not recovered; heavy headed on 02Feb2021 with outcome of not recovered; sore on 02Feb2021 with outcome of not recovered. The events were reported as non-serious as no treatment was given for them. Prior to vaccination, no diagnosis of COVID-19 was noted, and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
39 2021-03-08 bell's palsy Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable ph... Read more
Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable physician. A 39-year-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 20Jan2021, first dose on 30Dec2020, both at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none. Known allergies was no. If COVID prior vaccination was no. If COVID tested post vaccination was no. If other vaccine in four weeks was no. Other medications in two weeks was no. Concomitant medications were not reported. Patient developed right Bells Palsy on 18Feb2021. AE resulted in emergency room/department or urgent care. AE treatment included prednisone, magnetic resonance imaging (MRI) in Feb2021. The outcome of the event was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, drug causality cannot be completely excluded. Serious Facial paralysis may be considered as late sequel to BNT162B2 injection, due to appropriate chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-03-09 tingling Left hand tingling and cold.; Left hand tingling and cold.; This is a spontaneous report from a cont... Read more
Left hand tingling and cold.; Left hand tingling and cold.; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9264), via an unspecified route of administration in left arm on 06Feb2021 15:30 at single dose for COVID-19 immunisation. Medical history included asthma. She had no known allergies. Concomitant medication included beclometasone dipropionate (QVAR) and mometasone furoate (FLONASE). The patient experienced left hand tingling and cold on 06Feb2021 15:30. No treatment received for the events. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. The outcome of the events was recovering.
39 2021-03-15 numbness felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her... Read more
felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her scalp; heat in her chest; right side felt numb from her leg to her shoulder; hot flashes; This is a spontaneous report from a contactable consumer. A non-pregnant 39-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 19Jan2021 at 39-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history included heart murmur, Latex allergy; both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported; and no other medications were received within two weeks of the suspect vaccine. On 19Jan2021, the patient experienced: felt intense heat in her armpit lymph nodes on the right side (non-serious), streaks of heat along the back of her scalp (non-serious), heat in her chest (non-serious), right side felt numb from her leg to her shoulder (non-serious), hot flashes (non-serious). The clinical course was reported as follows: The patient, ten minutes after the vaccination, felt intense heat in her armpit lymph nodes on the right side. This was followed by streaks of heat along the back of her scalp, and heat in her chest. After about an hour, the right side felt numb from her leg to her shoulder. The patient's "body stayed that way for about 20 hours." The patient also experienced hot flashes, which was not something that she ever had before. The patient feared getting the second dose because her body felt so off after the first dose. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination with the suspect vaccine. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
39 2021-03-18 tremor Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling ... Read more
Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-03-22 pain, migraine Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a s... Read more
Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included depression-anxiety and birth control use; the patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included vilazodone hydrochloride (VIIBRYD), drospirenone/ethinylestradiol betadex clathrate (YAZ) for birth control, clonazepam (KLONOPIN). The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 04Feb2021 at 15:00 (also reported as within 3 minutes post vaccination), the patient experienced headache as a sharp pain across the forehead. On 04Feb2021 at 15:00, the patient also experienced chills, body aches and tiredness that lasted 24 hours. The headache remained 6 days post vaccination as a severe migraine, as of an unspecified date in Feb2021, for which no medications worked. The patient iced, applied heat to the area, dark room, no sound for 2 days and finally was relieved with acupuncture. This headache was like no headache the patient had ever had and she had come very close to an emergency room visit but realized it was from the vaccine. The events "Headache/Sharp pain across the forehead" and severe migraine resulted in a healthcare professional visit and the patient was treated for these events with acupuncture. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "Headache/Sharp pain across the forehead" and severe migraine was resolving; chills, body aches and tiredness were resolved on 05Feb2021 at 15:00. Information on the lot/batch number has been requested.
39 2021-04-08 numbness Right leg numbness and unable to move it, partial right arm numbness and left leg numbness unable to... Read more
Right leg numbness and unable to move it, partial right arm numbness and left leg numbness unable to walk. Bladder infection secondary at time. Severe back pain.